Reported Jun 3, 2020 · Terminated
Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc…
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?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM |
| 2 | 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM |
| 3 | XL-105916 588500 RingLoc Hip System, Acetabular Liner, 36 MM, Size 26 Product Usage: Hemi hip arthroplasty. |
- Lot codes and dates
- Lot NumbersUDI Number 1) 752470 (01)00880304568785(17)220118(10)752470 854070 (01)00880304568785(17)220119(10)854070; 2) 094360 (01)00880304209688(17)220106(10)094360; 3) 588500 (01)00880304209688(17)220106(10)094360
- Amount recalled
- 58 units
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
- Nationwide
Why it was recalled
Potential presence of elevated endotoxin levels that exceed the specification limit
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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