Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
LIF AMP Recalled by Alphatec Spine, Inc. Due to Awl instrument adjustable drill button assembly assembled in...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Alphatec Spine, Inc. directly.
Affected Products
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,
Quantity: 29
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Alphatec Spine, Inc.
Alphatec Spine, Inc. has 45 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report