Reported Oct 18, 2023 · Ongoing
EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H
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?
- EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H
- REF942-01-40H
- Lot codes and dates
- UDI-DI00190446309833
- Lot629Z1114
- Expiration
March 302028
- Amount recalled
- 20
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
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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