Recall Z-1701-2009 ยท HSB Rod, Fixation, Intramedullary And Accessories
Zimmer Inc.
Zimmer ITST Intertrochanteric/subtrochanteric fixation tapered reamer, nonsterile; REF 2258-50-00.
| Date | Aug 4, 2009 (initiated Jun 5, 2009) |
| Status | Terminated |
| Reason | Reamers labeled as having a standard diameter may actually be the dimensions of an Asia reamer, and vice versa. |
| Root cause | Process control |
| Action | Zimmer sent an Urgent Device Recall letter dated 6/5/09 to all consignees and instructed to locate and return the products. |
| Quantity | 120 of both products |
| Distribution | Worldwide distribution: USA, China, Germany, Japan, Korea and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032367 | ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL Zimmer, Inc., Aug 12, 2003 |