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U.S. Department of Health and Human Services

Class 2 Device Recall LIF AMP, Adjustable Awl

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  Class 2 Device Recall LIF AMP, Adjustable Awl see related information
Date Initiated by Firm July 07, 2023
Date Posted August 28, 2023
Recall Status1 Open3, Classified
Recall Number Z-2475-2023
Recall Event ID 92776
Product Classification Awl - Product Code HWJ
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,
Code Information UDI-DI: 00190376228037, Lot: EM50715
Recalling Firm/
Manufacturer		 Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad CA 92008-6505
For Additional Information Contact
760-431-9286
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
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 QMSCompliance@atecspine.com Questions/concerns can be directed to 1-800-922-1356 or QMSCompliance@atecspine.com
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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