Z-1738-2008

Zimmer Spine Cyclone anterior cervical plate, 3 Level, 60MM (Ti-6Al-4V); REF 600-03-160

Name: Z-1738-2008 Zimmer Spine Cyclone anterior cervical plate, 3 Level, 60MM (Ti-6Al-4V); REF 600-03-160
Creator: Zimmer Inc.
Published: 2008-03-26
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-03-26 / Terminated / root cause: design

FDA source

Zimmer Inc. began a recall of Zimmer Spine Cyclone anterior cervical plate, 3 Level, 60MM (Ti-6Al-4V); REF 600-03-160 on 2008-03-26. The reason FDA records is "The screw locking cap may fracture when the surgeon rotates it into the locked position". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1738-2008
Status: Terminated
Initiated: 2008-03-26
Posted: 2008-09-01
Terminated: 2009-11-12
Recalling firm: Zimmer GmbH
Product: Zimmer Spine Cyclone anterior cervical plate, 3 Level, 60MM (Ti-6Al-4V); REF 600-03-160.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: The screw locking cap may fracture when the surgeon rotates it into the locked position.
Root cause tag: design
FDA 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.
Product codes and lots: All lots.

Product code KWQ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)