Reported Nov 2, 2022 · Ongoing
EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
Encore Medical, LP
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: Encore Medical, LP · 9800 Metric Blvd · Austin, TX · 78758-5445
Is this the product you have?
- EMPOWER 3D Knee Tibial Insert
- REF341-14-708. Orthopedic implant component
- Lot codes and dates
- UDI-DI/Lot00888912167055/132T1085
- Amount recalled
- 18
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
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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