Alphatec Spine, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2475-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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,

Product Classification:

Class II

Date Initiated: July 7, 2023

Date Posted: September 6, 2023

Recall Number: Z-2475-2023

Event ID: 92776

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.

Status: Ongoing

Product Quantity: 29

Code Information:

UDI-DI: 00190376228037, Lot: EM50715

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.

Voluntary or Mandated:

Voluntary: Firm initiated