Recall Z-1174-2017 ยท NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
Biomet U.K., Ltd.
Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System
| Date | Jan 5, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | Zimmer Biomet initiated a voluntary recall of the Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the ffected products by mailing letters via FedEx on 01/05/2017. Customers were instructed to Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in their inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within thr |
| Quantity | 72 units in total |
| Distribution | Worldwide Distribution in the states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, OK, SC, NJ and the countries of Foreign: THAILAND, JAPAN, NETHERLANDS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.