Recall Z-0539-05 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Zimmer Austin, Inc
MOST Options System Porous and Non-Porous Revision Stem Adapters, manufactured and distributed by Zimmer Austin, Inc., Austin, Texas 78717
| Date | Feb 15, 2005 (initiated Dec 17, 2004) |
| Status | Terminated |
| Reason | Risk of adapter disassociation from mating components when assembled improperly or when subjected to high-stress femoral applications. |
| Root cause | Other |
| Action | The firm initiated the recall via letter on December 17, 2004. The firm''s letter requests the return of all recalled product. |
| Quantity | 121 units |
| Distribution | The product was distributed in AZ, CA, NY, IL, FL, MD, OH, MI, WI, MO, TX and to Canada and Portugal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013031 | MOST OPTIONS SYSTEM Sulzer Orthopedics, Inc., Dec 7, 2001 |