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Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc. Recalls

All product recalls associated with Depuy Orthopaedics, Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Mar 2024

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 61–77 of 77 recalls

Depuy Orthopaedics, Inc.: Depuy P.F.C. E knee system, all polyethylene curved tibia...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy P.F.C. E RP Knee System, rotating platform stabiliz...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy P.F.C. Modular Knee System, curved tibial insert (C...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

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FDA

May 26, 2005

Nationwide

• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy SIGMA RP TC3 insert; polyethylene tibial insert, Sz...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy P.F.C. SIGMA RPF tibial insert; polyethylene tibial...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy P.F.C. SIGMA curved insert; polyethylene tibial ins...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy P.F.C. E knee system, TC3 tibial insert; polyethyle...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy SIGMA curved plus insert; polyethylene tibial inser...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy LCS Complete RP insert; polyethylene tibial insert ...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: P.F.C. Modular Knee System Modular Plus Tibial Wedge 10...

Screw size included in system was incorrect

FDAJan 15, 2004IA• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: P.F.C. Knee System 7 Fluted Femoral Stem 18mmX12...

The collar was incorrectly etched for the R (right) and L (Left) orientation

FDADec 22, 2003NY• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy brand ACE trochanteric nail; sterile, long, left hi...

The lag screw may migrate to the femoral head or into the abdominal cavity.

FDADec 11, 2003Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: ProVision Hytrel Universal Hood/Gown; product 5431-31-000

Lack of assurance of sterility, due to the possibility of an incomplete package seal.

FDAJun 27, 2003Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: ProVision Barrier Universal Hood/Gown; product 5431-33-000

Lack of assurance of sterility, due to the possibility of an incomplete package seal.

FDAJun 27, 2003Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: ProVision Disposable Hood; product 5431-50-000

Lack of assurance of sterility, due to the possibility of an incomplete package seal.

FDAJun 27, 2003Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: ProVision Hytrel Elastomer Hood; product 5431-05-000.

Lack of assurance of sterility, due to the possibility of an incomplete package seal.

FDAJun 27, 2003Nationwide• Depuy Orthopaedics, Inc.