Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System, stabilized all-polyethylene tibia, Sz 2, 12.5 mm; Ref 96-2622. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Depuy P.F.C. E Knee System, stabilized all-polyethylene tibia, Sz 2, 12.5 mm; Ref 96-2622.
Brand
Depuy Orthopaedics, Inc.
Lot Codes / Batch Numbers
Lots 83422A, 84687A and 84791A.
Products Sold
Lots 83422A, 84687A and 84791A.
Depuy Orthopaedics, Inc. is recalling Depuy P.F.C. E Knee System, stabilized all-polyethylene tibia, Sz 2, 12.5 mm; Ref 96-2622. due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
The following details were not provided by the FDA: corrective action details.
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026