Alphatec Spine, Inc. 1950 Camino Vida Roble 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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,
Brand
Alphatec Spine, Inc. 1950 Camino Vida Roble
Lot Codes / Batch Numbers
UDI-DI: 00190376228037, Lot: EM50715
Products Sold
UDI-DI: 00190376228037, Lot: EM50715
Alphatec Spine, Inc. 1950 Camino Vida Roble is recalling LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Syst due to Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the des. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026