Reported Jun 7, 2023 · Ongoing
Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LEFT…
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?
26 of 26 products
| Model / number | Product as published |
|---|---|
1-10013-109 | SIZE 1-LEFT MED, 9MM |
1-10013-110 | SIZE 1-LEFT MED, 10MM |
1-10013-111 | SIZE 1-LEFT MED, 11MM |
1-10013-113 | SIZE 1-LEFT MED, 13MM |
1-10013-159 | SIZE 1-RIGHT MED, 9MM |
1-10013-160 | SIZE 1-RIGHT MED, 10MM |
1-10013-161 | SIZE 1-RIGHT MED, 11MM |
1-10013-163 | SIZE 1-RIGHT MED, 13MM |
1-10013-209 | SIZE 2-LEFT MED, 9MM |
1-10013-210 | SIZE 2-LEFT MED, 10MM |
1-10013-211 | SIZE 2-LEFT MED, 11MM |
1-10013-213 | SIZE 2-LEFT MED, 13MM |
1-10013-259 | SIZE 2-RIGHT MED, 9MM |
1-10013-260 | SIZE 2-RIGHT MED, 10MM |
1-10013-261 | SIZE 2-RIGHT MED, 11MM |
1-10013-263 | SIZE 2-RIGHT MED, 13MM |
1-10013-309 | SIZE 3-LEFT MED, 9MM |
1-10013-310 | SIZE 3-LEFT MED, 10MM |
1-10013-311 | SIZE 3-LEFT MED, 11MM |
1-10013-313 | SIZE 3-LEFT MED, 13MM |
- Amount recalled
- 7531 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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