Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0949-03

Alpha Mirage Top Tightening Spinal System 5.5 mm x 45 mm Length Bone Screws

Alphatec Spine, Inc. / initiated 2002-05-30 / Terminated

Alphatec Mfg Inc began a recall of Alpha Mirage Top Tightening Spinal System 5.5 mm x 45 mm Length Bone Screws on . The reason FDA records is "Laser marking is wrong on bone screws, says 40 and is 45 mm long". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0949-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Alphatec Spine, Inc.
Product
Alpha Mirage Top Tightening Spinal System 5.5 mm x 45 mm Length Bone Screws
Reason for recall
Laser marking is wrong on bone screws, says 40 and is 45 mm long.
FDA root cause
Other
Action
Customers were notified by fax in a letter dated May 19, 2003. All customers have been notified.
Quantity in commerce
31
Distribution
To FL, MD, CA, TX, Greece and Japan
Product codes and lots
Lot 251219G