Reported Sep 1, 2021 · Ongoing
AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000,…
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?
- AltiVate Anatomic Shoulder
- System for the following Part Numbers
1. Part # 520-08-00Rev. C2. Part # 520-10-0003. Part # 520-12-0004. Part # 520-14-0005. Part # 520-16-000
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 520-08-000 / 85OU1108; 85OU1110; 85OU1111 2 520-10-000 / 851U1256; 851U1257; 851U1258; 851U1259 3 520-12-000 / 852U1402; 852U1393; 852U1404; 852U1395; 852U1398A, 852U1405; 852U1397; 852U1391; 852U1400; 852U1398; 852U1407; 852U1396; 852U1406 4 520-14-000 / 853U1234; 853U1240; 853U1241A; 853U1238; 853U1239; 853U1237; 853U1241 5 520-16-000 / 854U1076; 854U1077 - Amount recalled
- N/A
Where it was sold
Why it was recalled
Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery.
This product could cause temporary or reversible health problems — stop using it.
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