PlainRecalls
FDA Devices Moderate Class II Ongoing

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,

Reported: September 6, 2023 Initiated: July 7, 2023 #Z-2475-2023

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.

Details

Recalling Firm
Alphatec Spine, Inc.
Units Affected
29
Distribution
US Nationwide distribution in the states of CT, IN, TX, LA, OH, AL, NH, MA, NC, AZ, MD, NJ, IL, CA, UT, MI.
Location
Carlsbad, CA

Frequently Asked Questions

What product was recalled? ▼
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,. Recalled by Alphatec Spine, Inc.. Units affected: 29.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 6, 2023. Severity: Moderate. Recall number: Z-2475-2023.

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