Recall Z-2475-2023— Alphatec Spine, Inc.
Class II · Ongoing
Class II FDA medical device recall by Alphatec Spine, Inc., initiated 2023-07-07. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Alphatec Spine, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-07
- Firm location
- Carlsbad, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.