| Class 2 Device Recall Zimmer Spine Cyclone anterior cervical plate system | |
Date Initiated by Firm | March 26, 2008 |
Date Posted | September 01, 2008 |
Recall Status1 |
Terminated 3 on November 12, 2009 |
Recall Number | Z-1742-2008 |
Recall Event ID |
47527 |
510(K)Number | K031214 K040397 |
Product Classification |
Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
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Product | Zimmer Spine Cyclone anterior cervical plate, 4 Level, 64MM (Ti-6Al-4V); REF 600-04-164. |
Code Information |
All lots. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E Main St Warsaw IN 46580-2746
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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 |
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. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = KWQ
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