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.
Take action
Contact the company
📍Recalling firmAlphatec Spine, Inc.1950 Camino Vida Roble · Carlsbad, CA 92008-6505
“Alphatec LIF AMP Awl Recall: Incorrect Assembly Risk of Dural Tear.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57737-alphatec-lif-amp-awl-recall-incorrect-assembly-risk-of-dural. Based on FDA recall #Z-2475-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2475-2023%22&limit=1).
The FDA announced on July 7, 2023, that Alphatec Spine, Inc. is recalling the LIF AMP Adjustable Awl (REF 117-165) due to a manufacturing defect that may cause over-insertion and patient injury. This Class II recall affects 29 units distributed nationwide.
How to tell if you have it
Brand: Alphatec
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
UDI-DI: 00190376228037
Lot: EM50715
Quantity: 29 units
Distribution: US Nationwide in CT, IN, TX, LA, OH, AL, NH, MA, NC, AZ, MD, NJ, IL, CA, UT, MI
The hazard
According to the FDA, the awl instrument's adjustable drill button assembly was assembled in the incorrect orientation, preventing the locking feature from engaging. This lack of depth control may lead to over-insertion, dural tear, vascular or neurologic injury, adjacent tissue damage, increased operative time, or revision surgery.
Context
GovInfoNow's records show Alphatec Spine, Inc. has had six other recalls since April 26, 2021. Recent brand recalls include the SafeOp Patient Interface Software Issue on May 13, 2026, and the LIF NAV Osteotome 10mm recall on Jan. 2, 2026. Other recent recalls of similar products include the Howmedica DURACON XL Angled Tibial Implants Recall (July 30, 2026), the U2 Total Knee System Femoral Valgus Adaptor Recall (May 20, 2026), and the Innovasis Anti-Torque Vector Pedicle Screw LS-749 Recall (May 22, 2026).
How to tell if you have this one
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.
Brand
Alphate:ec
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Look for the model number REF 117-165 on the device.
Contact Manufacturer
Reach out to Alphatec Spine, Inc. for further guidance on the recall.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 16 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CT, IN, TX, LA, OH, AL, NH, MA, NC, AZ, MD, NJ, IL, CA, UT, MI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Connecticut, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, North Carolina, Ohio, Texas, Utah.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2475-2023 (July 7, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2475-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.