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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Spine Cyclone anterior cervical plate system

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 Class 2 Device Recall Zimmer Spine Cyclone anterior cervical plate systemsee related information
Date Initiated by FirmMarch 26, 2008
Date PostedSeptember 01, 2008
Recall Status1 Terminated 3 on November 12, 2009
Recall NumberZ-1748-2008
Recall Event ID 47527
510(K)NumberK031214 K040397 
Product Classification Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
ProductZimmer Spine Cyclone anterior cervical plate, 4 Level, 88MM (Ti-6Al-4V); REF 600-04-188.
Code Information All lots.
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-777-7505
Manufacturer Reason
for Recall
The screw locking cap may fracture when the surgeon rotates it into the locked position.
FDA Determined
Cause 2
Device Design
ActionConsignees 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.
DistributionArizona, California, Florida, Georgia, Louisiana, Michigan, Minnesota, Montana, New Hampshire, North Carolina, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KWQ
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