Recall Z-0317-2008 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Inc.
Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; REF 7712-35-02, Zimmer U.K. Ltd., SN3, 4FP, UK
| Date | Dec 15, 2007 (initiated Jun 28, 2007) |
| Status | Terminated |
| Reason | Clip Detachment: The retainer c-clip can detach from the instrument during use and may fall into the surgical wound |
| Root cause | Process control |
| Action | Zimmer notified their distributors via Product Recall Notification Letter dated 6/30/07 and instructed them to notify their customers of the recall and to pick up the product and return it to Zimmer. |
| Quantity | 62 (total for Z-0316-0317-2008) |
| Distribution | Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.