Recall Z-1734-2008 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Zimmer Inc.
Zimmer Spine Cyclone anterior cervical plate, 3 Level, 48MM (Ti-6Al-4V); REF 600-03-148.
| Date | Sep 1, 2008 (initiated Mar 26, 2008) |
| Status | Terminated |
| Reason | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Root cause | Device Design |
| Action | Consignees were notified via voicemail on 3/26/08 and a letter was sent to all distributors on 3/27/08 informing them that the plate should no longer be used and that all lots are being recalled. A letter dated 6/18/08 was issued to implant physicians recommending patient monitoring. Contact Zimmer Spine at 1-952-857-5636 for assistance. |
| Distribution | Arizona, California, Florida, Georgia, Louisiana, Michigan, Minnesota, Montana, New Hampshire, North Carolina, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin. |
| FDA record | Open on fda.gov |