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

FDA device recall Z-0036-2010 · posted 2009-10-08 · Terminated

Recall details

Recalling firm

Alphatec Spine, Inc.

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.

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.

Root cause

Employee error

Status

Terminated

Product code

LRP

Quantity affected

7 Screws

Distribution

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

Date initiated

2008-12-16

Date posted

2009-10-08

Date terminated

2009-11-13

Location

Carlsbad, CA