Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0498-2010

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

Alphatec Spine, Inc. / initiated 2009-01-28 / Terminated / root cause: design

Alphatec Spine, Inc. began a recall of ILLICO Posterior Thoracolumbar Access Retractor, Part Number: 73520 The ILLICO Posterior Thoracolumbar Access Retractor is an instrument that is intended for... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0498-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Alphatec Spine, Inc.
Product
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.
Product code
GAD Retractor
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.
Root cause tag
design
FDA root cause
Device Design
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.
Quantity in commerce
14
Distribution
AZ, CA, OR, TX, and Tokyo, Japan.
Product codes and lots
Lot number: 5271901