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Implants & Prosthetics

AllImplants & Prosthetics(226)Monitoring Devices(263)Diagnostic Equipment(818)Home Healthcare(223)Contact Lenses & Vision(17)Surgical Equipment(895)

226 recalls

per page
DSAART
Medium RiskFDA Device

AART Surgical Implants Recalled for Deviation from Specifications

  • Sold in 27 states
  • Sold at Authorized medical distributors, Surgical centers +1 more
Recalled
Added
Limacorporate S.p.A
Medium RiskFDA Device

PRIMA Eccentrical Adaptors Recalled for Missing Positioning Markers

  • Sold in 6 states
  • Sold at Medical distributors
Recalled
Added
Tornier
Medium RiskFDA Device

Tornier, Inc: Tournier Perform Reversed Lateralized Baseplates Recalled for Assembly Defect

  • Sold in 10 states
  • Sold at hospitals, surgical centers +1 more
Recalled
Added
Exactech
Medium RiskFDA Device

Exactech, Inc.: UHMWPE Knee Patella Components Recalled for Packaging Defect

  • Distributed nationwide
  • Sold at hospitals, surgical centers +1 more
  • Premature wear and potential revision surgery due to polyethylene degradation.
Recalled
Added
Exactech
Medium RiskFDA Device

Exactech, Inc.: Various Joint Replacement Systems Recalled for Packaging Vacuum Loss

  • Sold in 16 states
  • Sold at authorized healthcare facilities, hospitals +1 more
  • 3 complaints for 4 devices regarding loss of vacuum; no specific physical injuries detailed.
Recalled
Added
Medium RiskFDA Device

Waldemar Link GmbH & Co. KG (Mfg Site): Tibial Components Recalled for Screws That Cannot Be Loosened During Surgery

  • Distributed nationwide
  • Sold at Authorized medical distributors
  • Prolongation of surgery and intraoperative change in procedure reported.
Recalled
Added
Tornier
Medium RiskFDA Device

Tornier, Inc: Perform Humeral Nucleus Recalled for Potential Bacterial Endotoxin Contamination

  • Sold in 5 states
  • Sold at hospitals, surgical centers
  • Bacterial Endotoxins contamination
Recalled
Added
CORENTEC
Medium RiskFDA Device

CORENTEC CO., LTD: LOSPA Knee System Tibial Inserts and Patella Components with Expiration Issues

  • Sold in 6 states
  • Sold at Authorized Medical Distributors, Hospitals +1 more
Recalled
Added
Zimmer
Medium RiskFDA Device

Zimmer, Inc.: NexGen CR-Flex Femoral Components Recalled for Potential Pad Detachment

  • Sold in 30 states
  • Sold at Hospitals, Orthopedic Surgery Centers +1 more
Recalled
Added
Dentsply IH
Medium RiskFDA Device

Atlantis IO FLO-S Kits Recalled for Threading Defect

  • Sold in 13 states
  • Sold at Dental suppliers, Direct distribution
Recalled
Added
Howmedica Osteonics
Medium RiskFDA Device

Howmedica Osteonics Corp.: UNITRAX Endoprosthesis Head Components Recalled for Mislabeled Sizes

  • Distributed nationwide
  • Sold at Hospitals, Surgical Centers
Recalled
Added
Thoratec
Medium RiskFDA Device

HeartMate LVAS Kits and Controllers Recalled for Battery Connector Corrosion

  • Distributed nationwide
  • Sold at Hospitals, Specialty Cardiac Centers
  • 67,107 units affected
Recalled
Added
Innovasis
Medium RiskFDA Device

Innovasis, Inc: Lumbar Fusion Device Implant Trials Recalled for Inserter Interfacing Issues

  • Sold in 9 states
  • Sold at Hospitals, Surgical sites +1 more
Recalled
Added
Ossur H / F
Medium RiskFDA Device

Ossur H / F: Power Knee and Batteries Recalled Due to Unexpected Shutdown and Fall Risk

  • Sold in 43 states
  • Sold at Authorized prosthetic clinics, Medical device distributors
Recalled
Added
Exactech
Medium RiskFDA Device

Exactech AcuMatch, Novation, and Alteon Hip Liners Recalled for Packaging Defect

  • Sold in 22 states
  • Sold at hospitals, surgical centers +1 more
  • Oxygen contamination
Recalled
Added
Medium RiskFDA Device

Vercise Deep Brain Stimulation Systems Recalled for Wire Break Risk

  • Sold in 45 states
  • Sold at Hospitals, Surgical centers +1 more
  • Wire breaks reported requiring device removal and replacement, resulting in return of symptoms and loss of therapy.
Recalled
Added
Howmedica Osteonics
Medium RiskFDA Device

Exeter V40 Stems Recalled for Mislabeled Packaging and Product Mix

  • Distributed nationwide
  • Sold at Hospitals, Surgical Centers
Recalled
Added
Medium RiskFDA Device

Boston Scientific Neuromodulation Corporation: WaveWriter Alpha Spinal Cord Stimulators Recalled for Potential Device Reset

  • Sold in 50 states
  • Sold at Hospitals, Surgical Centers +1 more
  • Patients experiencing undesired sensations leading to requests for surgical intervention for replacement or revision.
Recalled
Added
Medtronic Neuromodulation
Medium RiskFDA Device

Medtronic SynchroMed II and III Implantable Pumps Recalled for Software Issues

  • Distributed nationwide
  • Sold at Authorized Medical Distributors, Specialized Healthcare Facilities
Recalled
Added
Howmedica Osteonics
Medium RiskFDA Device

Howmedica Osteonics Corp.: Triathlon Knee System Inserts Recalled for Sterile Packaging Breaches

  • Distributed nationwide
  • Sold at Direct distribution to hospitals and surgical centers
Recalled
Added
Medtronic
High RiskFDA Device

Medtronic Azure S DR MRI SureScan Recalled for Sudden Battery Failure

  • Distributed nationwide
  • Sold at International distribution (UK)
Recalled
Added
Abbott Medical
Medium RiskFDA Device

Abbott Navitor Heart Valves Recalled for Manufacturing Error

  • Sold in New York
  • Sold at Hospitals, Medical facilities
Recalled
Added
TriMed
Medium RiskFDA Device

TriMed Inc.: Volar Bearing Plates Recalled Due to Bearings Popping Out During Surgery

  • Sold in 5 states
  • Sold at hospitals, surgical centers +1 more
Recalled
Added
Staar Surgical AG
Medium RiskFDA Device

EVO+ Visian Toric Implantable Collamer Lenses Recalled for Sizing Error

  • Distributed nationwide
  • Sold at specialty medical distributors
Recalled
Added