Date Initiated by Firm |
December 16, 2008 |
Date Posted |
October 08, 2009 |
Recall Status1 |
Terminated 3 on November 13, 2009 |
Recall Number |
Z-0036-2010 |
Recall Event ID |
52760 |
Product Classification |
Surgical Tray - Product Code LRP
|
Product |
ROC 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 |
Recalling Firm/ Manufacturer |
Alphatec Spine, Inc. 5818 El Camino Real Carlsbad CA 92008-8816
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For Additional Information Contact |
760-494-9286
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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 |
Action |
Alphatec 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 Commerce |
7 Screws |
Distribution |
Nationwide Distribution -- Including states of TX, FL, & NJ. |
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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