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U.S. Department of Health and Human Services

Class 2 Device Recall GE Anterior Cervical Post

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 Class 2 Device Recall GE Anterior Cervical Postsee related information
Date Initiated by FirmMay 31, 2006
Date PostedOctober 03, 2006
Recall Status1 Terminated 3 on July 27, 2011
Recall NumberZ-0001-2007
Recall Event ID 35637
510(K)NumberK024012 
Product Classification Cervical post - Product Code JAA
ProductGE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Code Information ALL LOT NUMBERS -GE Part number 1006385 or 1006385-NAV
FEI Number 1720753
Recalling Firm/
Manufacturer		 GE OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information Contact
801-328-9300
Manufacturer Reason
for Recall		Weld defect- the weld between the post body and the screw was not properly formed and can fail, even when minimal force is used.
FDA Determined
Cause 2		Process control
ActionConsignees were notified by letter on 05/31/2006
Quantity in Commerce143 units
DistributionNationwide, including one VA facility in PA. No military distribution. Foreign distribution to Canada, China, Italy, Japan, Spain.
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 = JAA
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