FDA Device recall Z-1157-2017
Oxford Partial Knee System Left Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System
- FDA Device
- Class II
- terminated
- Published 2017-03-01
On 2017-03-01 the FDA classified a Class II recall of Oxford Partial Knee System Left Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System by Biomet U K, citing zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to pr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1157-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-05 |
| Published | 2017-03-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomet U K |
| Distribution | AR, CA, KS, KY, LA, MA, MO, MT, NC, NJ, NY, OK, SC, TX |
Product
Oxford Partial Knee System Left Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Reason
Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
Identifiers
| code_info | Item: 32-420822, Lots: ZB160501 ZB160601 ZB160701 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1157-2017%22
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