Stryker Instruments Div. of Stryker Corporation: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Agency Publication Date: June 11, 2014

Affected Products

Product: Stryker 0.5mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostos

Part Number 5820-10-5, Lot Number 13354017

Lot Numbers:

Number

Product: Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynost

Part Number 5820-10-10, Lot Number 14005017

Lot Numbers:

Number

Product: Stryker 2.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynos

Part Number 5820-10-20, Lot Numbers 13347017,14010017

Lot Numbers:

Numbers

Product: Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostos

Part Number 5820-10-40, Lot Numbers 13344017

Lot Numbers:

Numbers

Product: Stryker 6.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostos

Part Number 5820-10-60, Lot Numbers 13343017

Lot Numbers:

Numbers

Product: Stryker 3.0mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Cr

Part Number 5820-10-130, Lot Numbers 13346017, 13346027

Lot Numbers:

Numbers

Product: Stryker 5.5mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Cr

Part Number 5820-10-155, Lot Number 13346017

Lot Numbers:

Number

Product: Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Cr

Part Number 5820-10-230, Lot Number 13343017

Lot Numbers:

Number

Product: Stryker 4.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Cr

Part Number 5820-10-245, Lot Number 13350017

Lot Numbers:

Number

Product: Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Cr

Part Number 5820-10-250, Lot Numbers 13336017, 13339017, 13340017, 13344017

Lot Numbers:

Numbers

Product: Stryker 5.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Cr

Part Number 5820-10-255, Lot Numbers 13354017, 14013017

Lot Numbers:

Numbers

Product: Stryker 6.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Cr

Part Number 5820-10-260, Lot Numbers 13346017

Lot Numbers:

Numbers

Product: Stryker 2.0mm Tapered Round Elite Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Cranio

Part Number 5820-10-320, Lot Numbers 14009017

Lot Numbers:

Numbers

Product: Stryker 3.5mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and C

Part Number 5820-10-635, Lot Numbers 13354017

Lot Numbers:

Numbers

Product: Stryker 5.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and C

Part Number 5820-10-650, Lot Number 14005027

Lot Numbers:

Number

Product: Stryker 6.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and C

Part Number 5820-10-660, Lot Number 13352017

Lot Numbers:

Number

Product: Stryker 2.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and C

Part Number 5820-10-920, Lot Number 13344017

Lot Numbers:

Number

Product: Stryker 5.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.

Part Number 5820-15-50, Lot Number 13343017

Lot Numbers:

Number

Product: Stryker 6.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.

Part Number 5820-15-60, Lot Number 14002017

Lot Numbers:

Number

Product: Stryker 5.0mm Barrel Bur Sterile

Part Number 5820-17-50, Lot Number 13345017

Lot Numbers:

Number

Product: Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.

Part Number 5820-30-50, Lot Number 13347017

Lot Numbers:

Number

Product: Stryker 6.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.

Part Number 5820-30-60, Lot Number 13353017

Lot Numbers:

Number

Product: Lindemann Drill Short, 1.6mm Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosi

Part Number 5820-102-16, Lot Number 14006017

Lot Numbers:

Number

Product: Stryker 1.3mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostos

Part Number 5820-103-13, Lot Number 14004017

Lot Numbers:

Number

Product: Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostos

Part Number 5820-103-15, Lot Number 14004017

Lot Numbers:

Number

Product: Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and

Part Number 5820-107-25, Lot Number 13346017

Lot Numbers:

Number

Product: Stryker 3.0mm x 3.8mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and C

Part Number 5820-107-30, Lot Number 13351017, 14007017

Lot Numbers:

Number

Product: Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and

Part Number 5820-107-40, Lot Number 13339017

Lot Numbers:

Number

Product: Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosyno

Part Number 5820-107-430, Lot Number 13350017

Lot Numbers:

Number

Product: Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and

Part Number 5820-107-530, Lot Number 13332017, 13332027, 13332037, 13333017, 13333027, 13334017, 13334027, 13336017, 13336027, 13346017, 13347017, 13347027, 13347037, 14017017

Lot Numbers:

Number

Product: Stryker 5.0mm Barrel Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.

Part Number 5820-017-050S1, Lot Number 14015017

Lot Numbers:

Number

Product: Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixatio

Part Number 5820-107-430S1, Lot Number 14003017,14005017

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 68331

Status: Resolved

Manufacturer: Stryker Instruments Div. of Stryker Corporation

Manufactured In: United States

Units Affected: 32 products (27; 72; 252; 281; 256; 609; 99; 285; 62; 1537; 84; 301; 6; 39; 4; 107; 4; 144; 65; 15; 71; 59; 12; 176; 246; 41; 802; 188; 497; 6481; 1; 916)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Part Number 5820-10-5, Lot Number 13354017

Lot Numbers:

Number

Part Number 5820-10-10, Lot Number 14005017

Lot Numbers:

Number

Part Number 5820-10-20, Lot Numbers 13347017,14010017

Lot Numbers:

Numbers

Part Number 5820-10-40, Lot Numbers 13344017

Lot Numbers:

Numbers

Part Number 5820-10-60, Lot Numbers 13343017

Lot Numbers:

Numbers

Part Number 5820-10-130, Lot Numbers 13346017, 13346027

Lot Numbers:

Numbers

Part Number 5820-10-155, Lot Number 13346017

Lot Numbers:

Number

Part Number 5820-10-230, Lot Number 13343017

Lot Numbers:

Number

Part Number 5820-10-245, Lot Number 13350017

Lot Numbers:

Number

Part Number 5820-10-250, Lot Numbers 13336017, 13339017, 13340017, 13344017

Lot Numbers:

Numbers

Part Number 5820-10-255, Lot Numbers 13354017, 14013017

Lot Numbers:

Numbers

Part Number 5820-10-260, Lot Numbers 13346017

Lot Numbers:

Numbers

Part Number 5820-10-320, Lot Numbers 14009017

Lot Numbers:

Numbers

Part Number 5820-10-635, Lot Numbers 13354017

Lot Numbers:

Numbers

Part Number 5820-10-650, Lot Number 14005027

Lot Numbers:

Number

Part Number 5820-10-660, Lot Number 13352017

Lot Numbers:

Number

Part Number 5820-10-920, Lot Number 13344017

Lot Numbers:

Number

Part Number 5820-15-50, Lot Number 13343017

Lot Numbers:

Number

Part Number 5820-15-60, Lot Number 14002017

Lot Numbers:

Number

Product: Stryker 5.0mm Barrel Bur Sterile

Part Number 5820-17-50, Lot Number 13345017

Lot Numbers:

Number

Part Number 5820-30-50, Lot Number 13347017

Lot Numbers:

Number

Part Number 5820-30-60, Lot Number 13353017

Lot Numbers:

Number

Part Number 5820-102-16, Lot Number 14006017

Lot Numbers:

Number

Part Number 5820-103-13, Lot Number 14004017

Lot Numbers:

Number

Part Number 5820-103-15, Lot Number 14004017

Lot Numbers:

Number

Part Number 5820-107-25, Lot Number 13346017

Lot Numbers:

Number

Part Number 5820-107-30, Lot Number 13351017, 14007017

Lot Numbers:

Number

Part Number 5820-107-40, Lot Number 13339017

Lot Numbers:

Number

Part Number 5820-107-430, Lot Number 13350017

Lot Numbers:

Number

Part Number 5820-107-530, Lot Number 13332017, 13332027, 13332037, 13333017, 13333027, 13334017, 13334027, 13336017, 13336027, 13346017, 13347017, 13347027, 13347037, 14017017

Lot Numbers:

Number

Part Number 5820-017-050S1, Lot Number 14015017

Lot Numbers:

Number

Part Number 5820-107-430S1, Lot Number 14003017,14005017

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 68331

Status: Resolved

Manufacturer: Stryker Instruments Div. of Stryker Corporation

Manufactured In: United States

Units Affected: 32 products (27; 72; 252; 281; 256; 609; 99; 285; 62; 1537; 84; 301; 6; 39; 4; 107; 4; 144; 65; 15; 71; 59; 12; 176; 246; 41; 802; 188; 497; 6481; 1; 916)