LIF AMP — Class II medical device recall Z-2475-2023
Ongoing recall by Alphatec Spine, Inc., reported 2023-09-06, distributed nationwide. Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking fea
| Recall number | Z-2475-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alphatec Spine, Inc., Carlsbad, CA, United States |
| Recall initiated | 2023-07-07 |
| Classified | 2023-08-28 |
| Reported by FDA | 2023-09-06 |
| Distributed | Nationwide (US) |
| Quantity | 29 |
| UPC / GTIN / UDI-DI | 00190376228037 |
| Lot numbers | EM50715 |
| Model numbers | 117-165 |
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,
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2475-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.