Z-1746-2010

Trestle Anterior Cervical Plate 1-level assembly, Part Number: 61001-026. Alphatec Spine, Carlsbad, CA 92008...

Name: Z-1746-2010 Trestle Anterior Cervical Plate 1-level assembly, Part Number: 61001-026. Alphatec Spine, Carlsbad, CA 92008...
Creator: Alphatec Spine, Inc.
Published: 2009-08-25
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2009-08-25 / Terminated / root cause: labeling and UDI

FDA source

Alphatec Spine, Inc. began a recall of Trestle Anterior Cervical Plate 1-level assembly, Part Number: 61001-026. Alphatec Spine, Carlsbad, CA 92008. Intended for the temporary stabilization of the... on 2009-08-25. The reason FDA records is "The recall was initiated after the firm discovered that the affected lot was labeled incorrectly in that the packaging label indicates that the part number of the lot is 61002-026, which corresponds to a two-level...". 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-1746-2010
Status: Terminated
Initiated: 2009-08-25
Posted: 2010-06-02
Terminated: 2010-06-07
Recalling firm: Alphatec Spine, Inc.
Product: Trestle Anterior Cervical Plate 1-level assembly, Part Number: 61001-026. Alphatec Spine, Carlsbad, CA 92008. Intended for the temporary stabilization of the anterior spine during the development of fusion in patients.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: The recall was initiated after the firm discovered that the affected lot was labeled incorrectly in that the packaging label indicates that the part number of the lot is 61002-026, which corresponds to a two-level Trestle Anterior Cervical Plate implant.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Alphatec Spine initiated a recall communication via telephone beginning August 25, 2009. Customers were given an explanation of the problem and instructed to check their inventory for the affected product. The firm indicated that they would arrange to have Federal Express contact customers for pick-up of the affected product(s) and replacement product would be sent out immediately. For further information, contact Alphatec Spine at 1-800-922-1356.
Quantity in commerce: 13 units
Distribution: Nationwide Distribution -- AL, CA, FL, TN, TX and UT.
Product codes and lots: Lot Number: 5481103

Product code KWQ

K070681Class IINext Generation Anterior Cervical Plating SystemAlphatec Spine, Inc. / cleared 2007-05-04

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)