Recall Z-2698-2011 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Biomet U.K., Ltd.
Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138) This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis.
| Date | Jun 29, 2011 (initiated Apr 22, 2011) |
| Status | Terminated |
| Reason | This recall was initiated due to a customer complaint which reported that while peeling off the Tyvek lid on the blister pack, very little effort was required to remove it and this could lead to contamination of the device. |
| Root cause | Packaging |
| Action | Biomet sent a "FIELD SAFETY NOTICE" dated April 21, 2011, to all affected accounts. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product, locate and remove from inventory and quarantine pending return to their Bioment distributor. Customers were also instructed to complete and return the attached "Fax Back Response Form" to their local Biomet distributor. For questions customers should contact their local Biomet Contact. |
| Quantity | 12 devices |
| Distribution | Outside the US to Austria, Belgium, and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011138 | OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT Biomet, Inc., Jul 10, 2001 |