Recall Z-2475-2023 ยท HWJ Awl
Alphatec Spine, Inc.
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,
| Date | Aug 28, 2023 (initiated Jul 7, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.