Recall Z-1438-2012 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Biomet, Inc.
REF. CP113456, MAK OSS No Head Lock Pin, NO HEAD / WITH PLUG CO-CR-MO ALLOY/ARCOM UHMWPE STERILE, R, Biomet Orthopedics Warsaw, IN 46581. The MAK OSS No Head Metal Lock Pin is to be inserted into the anterior hole of the tibial bearing yoke to secure the OSS Axle in the correct position within the OSS Femoral component assembly.
| Date | Apr 19, 2012 (initiated Mar 20, 2012) |
| Status | Terminated |
| Reason | Biomet initiated this action after receiving complaints of the MAK OSS No Head Lock Pin dislodging from its intended position (post-initial surgery). An investigation was initiated and the available lots of the Lock Pin were evaluated and measured against print specifications. |
| Root cause | Component design/selection |
| Action | Biomet sent an "URGENT MEDICAL DEVICE SAFETY ALERT" letter dated March 20, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to continue monitoring implanted patients for disassociation of the pin component and report to Biomet. The Alert included a complete listing of device invoice history and patient information (if supplied). Contact the firm for confirmation of receipt of the notice and for questions at 574-372-3983. |
| Quantity | 64 units distributed |
| Distribution | Distributed in California and Pennsylvania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083779 | MAK OSS KNEE FEMORAL COMPONENTS Biomet Manufacturing Corp, Apr 3, 2009 |