Orthovita, Inc., dBA Stryker Orthobiologics.: There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.

Agency Publication Date: May 24, 2013

Affected Products

Product: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

Manufacturer Part Number 2090-0502, Lot Number Q1006003

Lot Numbers:

Number

Product: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 6", Part Number 2090-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

Manufacturer Part Number 2090-0505, Lot Number A1006027

Lot Numbers:

Number

Product: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

Manufacturer Part Number 2090-0501, Lot Numbers A1109035 and Q1006002

Lot Numbers:

Numbers

Product: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

Manufacturer Part Number 2090-0504, Lot Numbers A1006026 and A1111020

Lot Numbers:

Numbers

Product: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

Manufacturer Part Number 2110-0505, Lot Numbers E909002 and E909002R

Lot Numbers:

Numbers

Product: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

Manufacturer Part Number 2110-0526, Lot Numbers E908004R and E908004

Lot Numbers:

Numbers

Product: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

Manufacturer Part Number 2110-0501, Lot Numbers E909004R and E909004

Lot Numbers:

Numbers

Product: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4", Part Number 2110-0506 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

Manufacturer Part Number 2110-0506, Lot Number E909005R

Lot Numbers:

Number

Product: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

Manufacturer Part Number 2110-0525, Lot Numbers E909006R

Lot Numbers:

Numbers

Product: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

Manufacturer Part Number 2110-0504, Lot Number E909007R

Lot Numbers:

Number

Product: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8", Part Number 2110-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

Manufacturer Part Number 2110-0502, Lot Number E909008R

Lot Numbers:

Number

Product: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6", Part Number 2110-0524 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

Manufacturer Part Number 2110-0524, Lot Number E909009R and E909009R

Lot Numbers:

Number

Product: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

Manufacturer Part Number 2110-0503, Lot Numbers E908003R and E908002

Lot Numbers:

Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 63204

Status: Resolved

Manufacturer: Orthovita, Inc., dBA Stryker Orthobiologics.

Manufactured In: United States

Units Affected: 13 products (78; 164; 411; 155; 35; 27; 414; 19; 5; 7; 17; 12; 69)

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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

Manufacturer Part Number 2090-0502, Lot Number Q1006003

Lot Numbers:

Number

Manufacturer Part Number 2090-0505, Lot Number A1006027

Lot Numbers:

Number

Manufacturer Part Number 2090-0501, Lot Numbers A1109035 and Q1006002

Lot Numbers:

Numbers

Manufacturer Part Number 2090-0504, Lot Numbers A1006026 and A1111020

Lot Numbers:

Numbers

Manufacturer Part Number 2110-0505, Lot Numbers E909002 and E909002R

Lot Numbers:

Numbers

Manufacturer Part Number 2110-0526, Lot Numbers E908004R and E908004

Lot Numbers:

Numbers

Manufacturer Part Number 2110-0501, Lot Numbers E909004R and E909004

Lot Numbers:

Numbers

Manufacturer Part Number 2110-0506, Lot Number E909005R

Lot Numbers:

Number

Manufacturer Part Number 2110-0525, Lot Numbers E909006R

Lot Numbers:

Numbers

Manufacturer Part Number 2110-0504, Lot Number E909007R

Lot Numbers:

Number

Manufacturer Part Number 2110-0502, Lot Number E909008R

Lot Numbers:

Number

Manufacturer Part Number 2110-0524, Lot Number E909009R and E909009R

Lot Numbers:

Number

Manufacturer Part Number 2110-0503, Lot Numbers E908003R and E908002

Lot Numbers:

Numbers