Recall Z-0491-2010 ยท KWP Appliance, Fixation, Spinal Interlaminal
Alphatec Spine, Inc.
Zodiac Polyaxial Spinal Fixation System. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the ve
| Date | Dec 7, 2009 (initiated Nov 3, 2008) |
| Status | Terminated |
| Reason | Alphatec Spine recently discovered that this lot of screws has the incorrect length laser etched on one side of the screw body. As a result, they are conducting a voluntary recall of the Zodiac Titanium cannulated polyaxial screw 6.5 mm x 50 mm L. |
| Root cause | Error in labeling |
| Action | Alphatec Spine contacted consignees via phone on October 16, 2008 and requested that consignees immediately remove the Zodiac Titanium cannulated polyaxial screws (6.5 mm x 50 mm L) from the surgical set to help ensure that they will not be used in surgery. There is a script the company developed to assure consistent responses to customers, and a phone number for more information. The strategy calls for products to be returned to Alphatec Spine. The company will arrange to have Federal Express contact the consignees for pick-up of the screws. Follow up questions are directed to the compa |
| Quantity | 56 |
| Distribution | AZ, CA, FL, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042673 | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM Alphatec/Nexmed, Oct 27, 2004 |