Reported Oct 21, 2020 · Terminated
(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom
Biomet, 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: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom
9 of 9 products
| Model / number | Barcodes | Product as published |
|---|---|---|
110010458 | Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM | |
| — | Lot No. 710930 | |
| — | 00880304568747 | UDI No. (01) 00880304568747 (17) 230614 (10) 710930 |
11-165206 | EXP Date June 14th 2023 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, ArCom, 41 MM OD, 28 MM ID: , Lot No. 649750 | |
| — | 00880304001923 | UDI No. (01) 00880304001923 (17) 230614 (10) 649750 |
11-165228 | EXP Date June 14th 2023 (3) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Cup, ArCom, 52 MM OD, 28 MM ID | |
| — | Lot No. 433290 | |
| — | 00880304001930 | UDI No. (01) 00880304001930 (17) 230612 (10) 433290 |
| — | EXP Date June 12th 2023 |
- Amount recalled
- 48 devices
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
- Nationwide
Why it was recalled
Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.
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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