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Terminated

ILLICO Posterior Thoracolumbar Access Retractor, Part Number: 73520 The ILLICO Posterior Thoracolumbar Access Retractor is an instrument that is intended for use in a minimally invasive approach for surgical procedures. The retractor allows retraction of tissue through combination of articulating blades. Device will serve to provide access for surgeons to surgical site.

FDA Recall Z-0498-2010 · Posted 2009-12-11

Recalling FirmAlphatec Spine, Inc.
Recall StatusTerminated
Product CodeGAD
Date Initiated2009-01-28
Date Terminated2009-12-22
Product Quantity14

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.

Firm Action

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

Distribution Pattern

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

Official Source

View FDA Recall →

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

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