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,
FDA Recall Z-2475-2023 · Posted 2023-08-28
Recalling FirmAlphatec Spine, Inc.
Recall StatusOpen, Classified
Product CodeHWJ
Date Initiated2023-07-07
Product Quantity29
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.
Firm Action
On 7/7/23, recall notices were emailed to consignees who were asked to do the following:
1) Abstain from sale and/or use and return to the recalling firm.
2) Complete and return the response form via email to [email protected]
Questions/concerns can be directed to 1-800-922-1356 or [email protected]
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the states of CT, IN, TX, LA, OH, AL, NH, MA, NC, AZ, MD, NJ, IL, CA, UT, MI.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.