Recall Z-0672-06 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Inc.
Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; Part number 00-7712-035-02.
| Date | Mar 21, 2006 (initiated Feb 2, 2006) |
| Status | Terminated |
| Reason | A c-clip located near the rasp connection end of the instrument may detach during use and fall into the patient. |
| Root cause | Other |
| Action | Firm sales personnel were notified by letter dated 2/8/06 to visit each of their affected accounts and to remove the c-clip from the rasps or to remove the instrument from the hospital and return it to the firm. Similar instructions issued by letter dated 2/27/06 when the recall was extended to the two additional products. |
| Quantity | 495 Right and Left |
| Distribution | Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.