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Terminated

Zimmer Spine Cyclone anterior cervical plate, 2 Level, 44MM (Ti-6Al-4V); REF 600-02-144.

FDA Recall Z-1732-2008 · Posted 2008-09-01

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeKWQ
Date Initiated2008-03-26
Date Terminated2009-11-12

Reason for Recall

The screw locking cap may fracture when the surgeon rotates it into the locked position.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Arizona, California, Florida, Georgia, Louisiana, Michigan, Minnesota, Montana, New Hampshire, North Carolina, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040397MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEMEncore Medical L.P. · 2004-05-06K031214CYCLONE ANTERIOR CERVICAL PLATE SYSTEMEncore Medical L.P. · 2003-09-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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