Reported Jun 7, 2023 · Ongoing
Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1…
Smith & Nephew, 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: Smith & Nephew, Inc. · 1450 E Brooks Rd · Memphis, TN · 38116-1804
Is this the product you have?
16 of 16 products
| Model / number | Product as published |
|---|---|
1-10003-100 | (SIZE 1 Right Medial) |
1-10003-110 | (SIZE 1 Left Medial) |
1-10003-200 | (SIZE 2-Right Medial) |
1-10003-210 | (SIZE 2-Left Medial) |
1-10003-300 | (SIZE 3- Right Medial) |
1-10003-310 | (SIZE 3- Left Medial) |
1-10003-400 | (SIZE 4- Right Medial) |
1-10003-410 | (SIZE 4- Left Medial) |
1-10003-500 | (SIZE 5- Right Medial) |
1-10003-510 | (SIZE 5- Left Medial) |
1-10003-600 | (SIZE 6- Right Medial) |
1-10003-610 | (SIZE 6- Left Medial) |
1-10003-700 | (SIZE 7- Right Medial) |
1-10003-710 | (SIZE 7- Left Medial) |
1-10003-800 | (SIZE 8 - Right Medial) |
1-10003-810 | (SIZE 8 - Left Medial); Unicondylar knee prothesis |
- Amount recalled
- 1994 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.
This product could cause temporary or reversible health problems — stop using it.
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