FDA Device recall Z-2145-2020
Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System,…
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System,… by Biomet, citing potential presence of elevated endotoxin levels that exceed the specification limit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2145-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-17 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biomet |
| Distribution | US |
Product
Hip Products Item Number: 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.
Reason
Potential presence of elevated endotoxin levels that exceed the specification limit
Identifiers
| code_info | Lot Numbers: UDI Number 1) 752470 (01)00880304568785(17)220118(10)752470 854070 (01)00880304568785(17)220119(1…Lot Numbers: UDI 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2145-2020%22
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