FDA Device recall Z-2475-2023
LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System
- FDA Device
- Class II
- ongoing
- Published 2023-09-06
On 2023-09-06 the FDA classified a Class II recall of LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System by Alphatec Spine, citing awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments l….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2475-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-07 |
| Published | 2023-09-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Alphatec Spine |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI-DI: 00190376228037, Lot: EM50715 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2475-2023%22
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