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,
- Recall Initiated
- July 7, 2023
- Posted
- August 28, 2023
- Recall Number
- Z-2475-2023
- Quantity
- 29
- Firm Location
- Carlsbad, CA
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.
Distribution
US Nationwide distribution in the states of CT, IN, TX, LA, OH, AL, NH, MA, NC, AZ, MD, NJ, IL, CA, UT, MI.
Lot / Code Info
UDI-DI: 00190376228037, Lot: EM50715
Root Cause
Nonconforming Material/Component
Action Taken
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 QMSCompliance@atecspine.com Questions/concerns can be directed to 1-800-922-1356 or QMSCompliance@atecspine.com