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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMay 30, 2002
Date PostedJune 21, 2003
Recall Status1 Terminated 3 on December 30, 2003
Recall NumberZ-0949-03
Recall Event ID 26410
ProductAlpha Mirage Top Tightening Spinal System 5.5 mm x 45 mm Length Bone Screws
Code Information Lot 251219G
FEI Number 2027467
Recalling Firm/
Manufacturer		 Alphatec Mfg Inc
6110 Corte Del Cedro
Carlsbad CA 92009
For Additional Information ContactEllen A. Hicks
760-431-9286
Manufacturer Reason
for Recall		Laser marking is wrong on bone screws, says 40 and is 45 mm long.
FDA Determined
Cause 2		Other
ActionCustomers were notified by fax in a letter dated May 19, 2003. All customers have been notified.
Quantity in Commerce31
DistributionTo FL, MD, CA, TX, Greece and Japan
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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