Reported Apr 7, 2021 · Terminated
The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components…
DePuy Orthopaedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
- The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing
- Total Knee System - Product Usageconsists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint
- Lot codes and dates
- Lot#: 9543538
- Product Code
129433130GTIN 10603295025788 Lot#: 9553989
- Product Code
129433130GTIN 10603295025788 Lot#: 9554547
- Product Code
129433130GTIN 10603295025788 Lot#: 9554548
- Product Code
129433130GTIN 10603295025788 Lot#: 9554551
- Product Code
129433130GTIN 10603295025788 Lot#: 9548774
- Product Code
129433140GTIN 10603295025795 Lot#: 9548777
- Product Code
129433140GTIN 10603295025795 Lot#: 9554569
- Product Code
129433140GTIN 10603295025795
- Amount recalled
- 102 units total (Domestic: 0 units, Foreign: 162 units)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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