Alphatec recalls LIF AMP Adjustable Awl (REF 117-165) due to incorrect assembly causing dural tears and nerve damage during spine surgery. Affected units have UDI-DI 00190376228037 and lot EM50715.
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.
Alphatec is recalling its LIF AMP Adjustable Awl (REF 117-165) because it can be assembled incorrectly, leading to dural tears, nerve damage, or surgery complications. This affects surgeons using the device with specific spine systems.
The awl's adjustable drill button assembly may not lock properly when assembled, causing it to over-insert into the spine. This can tear the dura (protective membrane around the spinal cord), damage nerves, or require additional surgery.
Surgeons using the LIF AMP Awl with Alphatec's spine systems are affected. Those performing spinal procedures with the Transcend LIF, Battalion LLIF, or IdentiTi LIF systems are at highest risk.
Check for the model number REF 117-165 on the device. Affected units have UDI-DI 00190376228037 and lot number EM50715. The device is part of the AMP System used with specific spine systems.
Look for the model number REF 117-165 on the device.
Reach out to Alphatec Spine, Inc. for further guidance on the recall.
The recalled model is REF 117-165.
Affected units have lot number EM50715.
Incorrect assembly can cause dural tears, nerve damage, or require additional surgery.
We’ve drafted a message you can send Alphate:ec to request your refund or repair — edit it as you like.
Subject: Recall Z-2475-2023 — Alphate:ec Alphate:ec Hello, I own a Alphate:ec that is covered by recall Z-2475-2023 from Alphate:ec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
