Z-0269-2013Class II

TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The...

Name: Z-0269-2013 TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The...
Creator: Alphatec Spine, Inc.
Published: 2010-12-09
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2010-12-09 / Terminated / root cause: labeling and UDI

FDA source

Alphatec Spine, Inc. began a recall of TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended... on 2010-12-09. FDA classified it as Class II and gives the reason as "The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0269-2013
Classification: Class II
Status: Terminated
Initiated: 2010-12-09
Posted: 2012-11-08
Terminated: 2012-11-09
Recalling firm: Alphatec Spine, Inc.
Product: TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac Polyaxial Pedicle Screw System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Alphatec Spine distributors who received the TI Standard Polyaxial Screw Assembly were contacted by phone and by email on December 9, 2010. A phone script was used as a recall notification to contact their three distributors who received the recalled products. The recall notification informed the customers of the problem identified and the action to be taken. Customers were informed that they will receive replacements within 2-3 days. Customers with questions were instructed to call (800) 922-1356. For questions regarding this recall call 760-431-9286.
Quantity in commerce: 11 units
Distribution: Nationwide Distribution including TN, WI, and FL.
Product codes and lots: Lot # 634745

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0269-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0269-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-08

Product code KWP

K033090Class IIIcon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. / cleared 2004-03-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)