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U.S. Department of Health and Human Services

Class 2 Device Recall ROC Lumbar bolt caddy

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 Class 2 Device Recall ROC Lumbar bolt caddysee related information
Date Initiated by FirmDecember 16, 2008
Date PostedOctober 08, 2009
Recall Status1 Terminated 3 on November 13, 2009
Recall NumberZ-0036-2010
Recall Event ID 52760
Product Classification Surgical Tray - Product Code LRP
ProductROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Code Information Lot Number: 53298
FEI Number 2027467
Recalling Firm/
Manufacturer		 Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad CA 92008-8816
For Additional Information Contact
760-494-9286
Manufacturer Reason
for Recall		Alphatec discovered that the lot of bolt caddies had the incorrect bolt length laser etched on one side of the caddy. The actual ROC bolts themselves are correctly laser etched.
FDA Determined
Cause 2		Employee error
ActionAlphatec contacted consignees via phone on December 16, 2008 and informed consignees that they will arrange to have Federal Express contact them for pick-up. Consignees were asked to check their inventory to see where this product is located, and ensure that it is put on hold for return; and what days and hours they are in the office, (Confirm address: attach copy of the pick-up request form.) If they have any follow up questions, they were told to call 1-800-922-1356.
Quantity in Commerce7 Screws
DistributionNationwide Distribution -- Including states of TX, FL, & NJ.
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.
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