Reported Jun 7, 2023 · Ongoing
Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b)…
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?
- Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem
- Part Numbers
a) REF 1-10011-100 (SIZE 1-2)b) REF 1-10011-200 (SIZE 3-4)c) REF 1-10011-300 (SIZE 5-6)Unicondylar knee prothesis
- Lot codes and dates
a) REF 1-10011-100UDI/DI 00885556873083b) REF 1-10011-200UDI/DI 00885556873090c) REF 1-10011-300UDI/DI 00885556873106ALL BATCHES
- Amount recalled
- 1596 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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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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