FDA Device Recall Z-0036-2010: Alphatec Spine, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0036-2010.

Recall Res Number

Z-0036-2010

Recalling Firm / Manufacturer

Alphatec Spine, Inc.

FEI Number

2027467

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2008-12-16

Date Posted

2009-10-08

Date Terminated

2009-11-13

Product Code

LRP

Event Number

52760

Product Quantity

7 Screws

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

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 Details 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.

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

Code Information / Serial Numbers Lot Number: 53298

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Medical Device Recall: Z-0036-2010

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer