ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
This recall has been terminated (originally issued October 8, 2009).
- Company
- Alphatec Spine, Inc.
- Recall Initiated
- December 16, 2008
- Posted
- October 8, 2009
- Terminated
- November 13, 2009
- Recall Number
- Z-0036-2010
- Quantity
- 7 Screws
- Firm Location
- Carlsbad, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution -- Including states of TX, FL, & NJ.
Lot / Code Info
Lot Number: 53298
Root Cause
Employee error
Action Taken
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.