Recall Z-1124-2013 ยท NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
Biomet U.K., Ltd.
REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System Tibial instrument Tray small surgical hammer supplied with the Oxford Partial Knee Microplasty Instrument set, used for impacting implants.
| Date | Apr 15, 2013 (initiated Mar 20, 2013) |
| Status | Terminated |
| Reason | Investigation of complaints found excessive use of the instrument could result in cracking on the weld between the head and the handle, which could lead to part of the head becoming detached from the handle. |
| Root cause | Device Design |
| Action | BIOMET sent an Urgent Medical Device Recall Notice on March 20, 2013, to all affected customers with directions to forward the notice if product was further distributed to Hospital Operating Room managers. The notice identified the recalled device, reason for the recall, and possible adverse events directing consignees to locate and discontinue use of the device. A FAX back Response form was to be returned to 574-372-1683 within 3 days of receipt prior to return of the product to Biomet, USA. Questionsregarding this recall should be addressed to 574 372-1570 M-F, 8a.m. -5 p.m. |
| Quantity | 430 |
| Distribution | Worldwide Distribution - USA (nationwide), Europe, Japan, Australia, Canada, Singapore, South Africa, and Costa Rica. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.