FDA Medical Device Recalls (openFDA)
Alphatec Spine, Inc.: 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
- Recall number
- Z-2475-2023
- 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,
- Status
- Open, Classified
- Initiated
- 2023-07-07
- Posted
- 2023-08-28
- Terminated
- not on file
- Reason
- 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
- 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 QMSCompliance@atecspine.com Questions/concerns can be directed to 1-800-922-1356 or QMSCompliance@atecspine.com
- Quantity
- 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.
- Lot, serial or model codes
- UDI-DI: 00190376228037, Lot: EM50715
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWJ
- Firm FEI
- 2027467
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28