Z-2475-2023Class II

LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems...

Name: Z-2475-2023 LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems...
Creator: Alphatec Spine, Inc.
Published: 2023-07-07
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2023-07-07 / Open, Classified / root cause: manufacturing process

FDA source

Alphatec Spine, Inc. began a recall of LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF on 2023-07-07. FDA classified it as Class II and gives the reason as "Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2475-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-07
Posted: 2023-08-28
Recalling firm: Alphatec Spine, Inc.
Product: LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF,
Product code: HWJ Awl
Reason for recall: Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, increased operative time, revision surgery.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 7/7/23, recall notices were emailed to consignees who were asked to do the following: 1) Abstain from sale and/or use and return to the recalling firm. 2) Complete and return the response form via email to [email protected] Questions/concerns can be directed to 1-800-922-1356 or [email protected]
Quantity in commerce: 29
Distribution: US Nationwide distribution in the states of CT, IN, TX, LA, OH, AL, NH, MA, NC, AZ, MD, NJ, IL, CA, UT, MI.
Product codes and lots: UDI-DI: 00190376228037, Lot: EM50715

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2475-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2475-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-28

Product code HWJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)