Zimmer Spine Cyclone anterior cervical plate, 4 Level, 64MM (Ti-6Al-4V); REF 600-04-164.
This recall has been terminated (originally issued September 1, 2008).
- Company
- Zimmer Inc.
- Recall Initiated
- March 26, 2008
- Posted
- September 1, 2008
- Terminated
- November 12, 2009
- Recall Number
- Z-1742-2008
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The screw locking cap may fracture when the surgeon rotates it into the locked position.
Distribution
Arizona, California, Florida, Georgia, Louisiana, Michigan, Minnesota, Montana, New Hampshire, North Carolina, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin.
Lot / Code Info
All lots.
Root Cause
Device Design
Action Taken
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.
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