Zimmer ITST Intertrochanteric/subtrochanteric fixation tapered reamer, nonsterile; REF 2258-50-00.
FDA device recall Z-1701-2009 · posted 2009-08-04 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- Reamers labeled as having a standard diameter may actually be the dimensions of an Asia reamer, and vice versa.
- Action taken
- Zimmer sent an Urgent Device Recall letter dated 6/5/09 to all consignees and instructed to locate and return the products.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 120 of both products
- Distribution
- Worldwide distribution: USA, China, Germany, Japan, Korea and Thailand.
- Date initiated
- 2009-06-05
- Date posted
- 2009-08-04
- Date terminated
- 2009-12-22
- 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 |
|---|---|---|
| ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL (K032367) | Zimmer, Inc. | 2003-08-12 |