ILLICO Posterior Thoracolumbar Access Retractor, Part Number: 73520 The ILLICO Posterior Thoracolumbar Access Retractor

FDA device recall Z-0498-2010 · posted 2009-12-11 · Terminated

Recall details

Recalling firm

Alphatec Spine, Inc.

Reason for recall

The recall was initiated after Alphatec Spine received a complaint on the ILLICO Posterior Thoracolumbar access retractor. It was reported that one of the retractor arms in the retractor broke during surgery.

Action taken

On January 28, 2009 Alphatec Spine contacted their domestic consignees via telephone and the international consignee was contacted via telephone and electronic mail. Alphatec Spine's telephone call consisted of informing the consignees of the product affected, the problem, what actions needed to be taken and what action Alphatec Spine would take to arrange for pick-up of the affected products.

Root cause

Device Design

Status

Terminated

Product code

GAD

Quantity affected

14

Distribution

AZ, CA, OR, TX, and Tokyo, Japan.

Date initiated

2009-01-28

Date posted

2009-12-11

Date terminated

2009-12-22

Location

Carlsbad, CA