Recall Z-0190-2007 ยท KWP Appliance, Fixation, Spinal Interlaminal
Zimmer Spine, Inc.
Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Part number: 07.00684.00. Non-Sterile. Zimmer Spine, Inc., 7375 Bush Lake Road, Minneapolis, MN 55439 U.S.A. The Distal Thread Reduction Guide Pin is a reusable instrument that is part of a set of instruments used to perform reduction surgeries with the ST360 Spinal Fixation System. The ST360 Spinal Fixation System is a temporary implant
| Date | Nov 16, 2006 (initiated Oct 5, 2006) |
| Status | Terminated |
| Reason | Zimmer Spine, Inc. is conducting a RECALL of all manufacturing lots of ST360 Distal Thread Reduction Guide Pins due to an issue with the thread timing. |
| Root cause | Other |
| Action | Distributors were notified via email with an Urgent Product Recall letter beginning 10/12/2006. Distributors are to return their own inventory and any hospital consignment inventory by October 20, 2006. A Certification Form is also to be faxed back to Zimmer Spine. |
| Quantity | 159 |
| Distribution | Nationwide and Japan |
| FDA record | Open on fda.gov |