Reported Apr 4, 2018 · Terminated
(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP…
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?
10 of 10 products
| Model / number | Product as published |
|---|---|
10603295001614 | (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100 |
10603295001621 | (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200 |
10603295001638 | (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300 |
10603295001645 | (4) Sigma HP Cemented Trochlea Size 4 Narrow Left, Catalog Number: 102403400 |
10603295001652 | (5) Sigma HP Cemented Trochlea Size 5 Narrow Left, Catalog Number: 102403500 |
10603295001669 | (6) Sigma HP Cemented Trochlea Size 1 Narrow Right, Catalog Number: 102404100 |
10603295001676 | (7) Sigma HP Cemented Trochlea Size 2 Narrow Right, Catalog Number: 102404200 |
10603295001683 | (8) Sigma HP Cemented Trochlea Size 3 Narrow Right, Catalog Number: 102404300 |
10603295001690 | (9) Sigma HP Cemented Trochlea Size 4 Narrow Right, Catalog Number: 102404400 |
10603295001706 | (10) Sigma HP Cemented Trochlea Size 5 Narrow Right, Catalog Number: 102404500 |
- Lot codes and dates
- All lots
- Amount recalled
- 2110
Where it was sold
Why it was recalled
The SIGMA¿ HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as part of the company s post market surveillance process.
This product could cause temporary or reversible health problems — stop using it.
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