Go Backs

Implants & Prosthetics

AllImplants & Prosthetics(227)Monitoring Devices(261)Diagnostic Equipment(819)Home Healthcare(220)Contact Lenses & Vision(17)Surgical Equipment(896)

227 recalls

per page
Cartiva
Medium RiskFDA Device

Cartiva Synthetic Cartilage Implants Recalled Due to Higher Failure Rates

  • Sold in 35 states
  • Sold at Hospitals, Surgical Centers +1 more
  • Higher-than-expected rates of implant subsidence, displacement, nerve damage, and fragmentation requiring removal or revision.
Recalled
Added
Conformis
Medium RiskFDA Device

Conformis, Inc.: Identity Imprint PS Tibial Tray Recalled for Incorrect Sizing and Packaging

  • Sold in Florida, Kansas, New Hampshire
  • Sold at Hospital and surgical centers
Recalled
Added
Limacorporate S.p.A
Medium RiskFDA Device

Limacorporate S.p.A: PHYSICA HPS Tibial Liner Recalled Due to Incorrect Product Labeling

  • Sold in 5 states
  • Sold at Authorized medical distributors
Recalled
Added
Medium RiskFDA Device

Modular Stem Cylindrical Implants Recalled for Incorrect Packaging Labels

  • Sold in 14 states
  • Sold at Specialty medical distributors, Hospitals
Recalled
Added
SPINEART SA
Medium RiskFDA Device

SPINEART SA: PERLA TL Spinal Screws Recalled for Setscrew Insertion and Tightening Issues

  • Sold in California, Kentucky
  • Sold at Hospitals, Surgical Centers
Recalled
Added
FX SHOULDER
Medium RiskFDA Device

FX SHOULDER: Centered Glenosphere w/Screw Recalled for Incorrect Device in Box

  • Sold in New Jersey
  • Sold at specialty medical distributors, hospitals
Recalled
Added
Cerapedics
Medium RiskFDA Device

PearMatrix P-15 Bone Graft Recalled for Incorrect Expiration Date

  • Sold in 24 states
  • Sold at Hospitals, Surgical Centers +1 more
Recalled
Added
Spectranetics
Critical RiskFDA Device

Tack Endovascular System Recalled for Deployment and Stability Issues

  • Distributed nationwide
  • Sold at Hospitals, Surgical Centers +1 more
Recalled
Added
Encore Medical
Medium RiskFDA Device

EMPOWR 3D Knee Tibial Inserts Recalled for Incorrect Package Contents

  • Sold in 8 states
  • Sold at hospitals, surgical centers
Recalled
Added
Tornier
Medium RiskFDA Device

Tornier, Inc: Perform Reversed Glenoid Press-Fit Implants Recalled for Incorrect Device in Package

  • Sold in 9 states
  • Sold at Hospitals, Surgical Centers +1 more
Recalled
Added
Smith & Nephew
Medium RiskFDA Device

Smith & Nephew META-TAN Screw Kits Recalled for Fitting Issues

  • Sold in 19 states
  • Sold at Medical distributors, Hospitals
Recalled
Added
CORNEAT VISION
Medium RiskFDA Device

CorNeat EverPatch and EverPatch+ Recalled for Risk of Early Exposure

  • Sold in 29 states
  • Sold at Medical distributors, Direct to hospitals
  • Complaints of conjunctival wound dehiscence leading to early exposure reported.
Recalled
Added
Encore Medical
Medium RiskFDA Device

Encore Medical, LP: Shoulder Implant Socket Inserts Recalled for Incorrect Sizing Information

  • Sold in 13 states
  • Sold at hospitals, surgical centers +1 more
Recalled
Added
Edwards Lifesciences
Medium RiskFDA Device

Edwards Lifesciences, LLC: PASCAL Precision Valve Repair Systems Recalled for Implant Release Issues

  • Distributed nationwide
  • Sold at Authorized Medical Distributors, Edwards Lifesciences
Recalled
Added
IsoTis OrthoBiologics
Medium RiskFDA Device

OsteoSurge 100 Bone Matrix Recalled for Incorrect Expiration Dates

  • Sold in Indiana, Tennessee, Texas
  • Sold at Specialized medical distributors, Hospitals
Recalled
Added
Zimmer
Medium RiskFDA Device

Zimmer Biomet Dual Mobility Vivacit-E Bearings Recalled for Mismatched Sizes

  • Sold in 20 states
  • Sold at Zimmer Biomet, Medical distributors +2 more
Recalled
Added
Abbott Medical
Medium RiskFDA Device

Abbott Medical: There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).

  • 21,437 units affected
Recalled
Added
Thommen Medical AG
Medium RiskFDA Device

Thommen Medical AG: Impression Coping Recalled Due to Manufacturing Defect

  • Sold in Ohio, Kentucky
  • Sold at Specialty dental distributors
Recalled
Added
SEASPINE ORTHOPEDICS
Medium RiskFDA Device

SEASPINE ORTHOPEDICS CORPORATION: Mariner RDX MIS Pedicle Screw Heads Recalled for Cross-Threading Risk

  • Sold in 4 states
  • Sold at Authorized medical distributors, Specialty surgical centers
Recalled
Added
Osteotec
Medium RiskFDA Device

Osteotec Silicone Finger Implants Recalled for Potential Foreign Material

  • Sold in California
  • Sold at hospitals, surgical centers
  • Foreign material contamination
Recalled
Added
Orthofix U.S.
Medium RiskFDA Device

Orthofix Pillar SA Ti Spinal Implants Recalled for Incorrect Width Labeling

  • Sold in Colorado, California
  • Sold at Specialty medical distributors, Hospitals
Recalled
Added
W.L. Gore & Associates
Medium RiskFDA Device

W.L. Gore & Associates, Inc.: GORE VIABIL Biliary Endoprosthesis Recalled for Potential Mislabeled Drainage Holes

  • Sold in Georgia
  • Sold at Hospital supply chains, Medical device distributors
Recalled
Added
Synovo Production
Medium RiskFDA Device

Synovo Production: Medical Implant Components Recalled for Lack of FDA Clearance

  • Sold in Washington
  • Sold at Authorized Medical Distributors
Recalled
Added
Theken Companies
Medium RiskFDA Device

iNSitu Bipolar Hip System Recalled for Potential Sterile Barrier Issues

  • Sold in New Jersey, Pennsylvania, Texas
  • Sold at hospitals, surgical centers
Recalled
Added