Zimmer Natural Nail System, Connecting Knob, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-000-11. The device is used to d
FDA device recall Z-0388-2010 · posted 2009-11-24 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the threading method used.
- Action taken
- On July 1, 2009, U.S. distributors were notified by e-mail to return two instruments. The recall was expanded with international accounts notified by e-mail on August 5, 2009, and U.S. accounts being notified by e-mail on August 6, 2009, to return 7 instruments. The scope of the recall was then expanded again to include 14 instruments and another letter dated September 14, 2009 to distributors and user accounts. The notifications described the affected products, problem, health risks and actions for consignees. Direct questions about the recall to Zimmer, Inc. by calling 1-800-613-6131.
- Root cause
- Other
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 327 of total product
- Distribution
- Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and United Kingdom.
- Date initiated
- 2009-07-01
- Date posted
- 2009-11-24
- Date terminated
- 2011-10-05
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM (K090596) | Zimmer, Inc. | 2009-06-30 |
| ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS (K083497) | Zimmer, Inc. | 2009-02-19 |
| ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL (K082770) | Zimmer, Inc. | 2008-12-11 |