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.
FDA Recall Z-1746-2010 · Posted 2010-06-02
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Recalling FirmAlphatec Spine, Inc.
Recall StatusTerminated
Product CodeKWQ
Date Initiated2009-08-25
Date Terminated2010-06-07
Product Quantity13 units
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.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution -- AL, CA, FL, TN, TX and UT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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