FDA Device recall Z-0628-2021
RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Met…
- FDA Device
- Class II
- terminated
- Published 2020-12-23
On 2020-12-23 the FDA classified a Class II recall of RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Met… by Biomet, citing specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0628-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-25 |
| Published | 2020-12-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biomet |
| Distribution | US |
Product
RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented.
Reason
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Identifiers
| code_info | Lot 173500 |
|---|
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-0628-2021%22
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