FDA Device recall Z-1018-2023
Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femora…
- FDA Device
- Class II
- ongoing
- Published 2023-02-01
On 2023-02-01 the FDA classified a Class II recall of Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femora… by Biomet, citing packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1018-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-15 |
| Published | 2023-02-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomet |
| Distribution | US |
Product
Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 154341
Reason
Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier
Identifiers
| code_info | UDI: (01) 05019279515349 (17) 241123 (10) 077830 Lot Number: 077830 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1018-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.