AMP recallZ-2475-2023 · Alphatec Spine, Inc. · initiated Jul 7, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Alphatec Spine, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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]
Recall details
- Recall number
- Z-2475-2023
- Status
- Open, Classified
- Initiated by the company
- Jul 7, 2023
- Posted by the FDA
- Aug 28, 2023
- Recalling firm
- Alphatec Spine, Inc.
- Quantity
- 29
- Product code
- HWJ
- 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 description
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,
Code information (models, lots, serial numbers)
UDI-DI: 00190376228037, Lot: EM50715
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AMP 117-165Alphatec Spine, Inc. · AWL1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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