FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer Spine Cyclone anterior cervical plate, 3 Level, 54MM (Ti-6Al-4V); REF 600-03-154.
- Recall number
- Z-1736-2008
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer Spine Cyclone anterior cervical plate, 3 Level, 54MM (Ti-6Al-4V); REF 600-03-154.
- Status
- Terminated
- Initiated
- 2008-03-26
- Posted
- 2008-09-01
- Terminated
- 2009-11-12
- 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.
- Quantity
- not on file
- Distribution
- Arizona, California, Florida, Georgia, Louisiana, Michigan, Minnesota, Montana, New Hampshire, North Carolina, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- ["K031214","K040397"]
- PMA numbers
- not on file
- Product code
- KWQ
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28