MOST Options System Porous and Non-Porous Revision Stem Adapters, manufactured and distributed by Zimmer Austin, Inc., A
FDA device recall Z-0539-05 · posted 2005-02-15 · Terminated
Recall details
- Recalling firm
- Zimmer Austin, Inc
- Reason for recall
- Risk of adapter disassociation from mating components when assembled improperly or when subjected to high-stress femoral applications.
- Action taken
- The firm initiated the recall via letter on December 17, 2004. The firm''s letter requests the return of all recalled product.
- Root cause
- Other
- Status
- Terminated
- Product code
- KRO
- Quantity affected
- 121 units
- Distribution
- The product was distributed in AZ, CA, NY, IL, FL, MD, OH, MI, WI, MO, TX and to Canada and Portugal
- Date initiated
- 2004-12-17
- Date posted
- 2005-02-15
- Date terminated
- 2007-11-27
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOST OPTIONS SYSTEM (K013031) | Sulzer Orthopedics, Inc. | 2001-12-07 |