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Terminated

ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

FDA Recall Z-0036-2010 · Posted 2009-10-08

Recalling FirmAlphatec Spine, Inc.
Recall StatusTerminated
Product CodeLRP
Date Initiated2008-12-16
Date Terminated2009-11-13
Product Quantity7 Screws

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.

Firm 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.

Root Cause

Employee error

Distribution Pattern

Nationwide Distribution -- Including states of TX, FL, & NJ.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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