CLASS II ONGOING Device recall · Reported 6 Sep 2023 · FDA Enforcement Report
LIF AMP, Adjustable Awl recalled by Alphatec Spine
Alphatec Spine is recalling LIF AMP, Adjustable Awl, distributed nationwide in the US. The recall was initiated on 7 Jul 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2475-2023
- FDA event ID
- 92776
- Recalling firm
- Alphatec Spine, Carlsbad, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Jul 2023
- FDA classified
- 28 Aug 2023
- Reported
- 6 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 7 Jul 2023 | Recall initiated by company | |
| 28 Aug 2023 | Classified by FDA | +52 days |
| 6 Sep 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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,
Where it was distributed
US Nationwide distribution in the states of CT, IN, TX, LA, OH, AL, NH, MA, NC, AZ, MD, NJ, IL, CA, UT, MI.
Nationwide AlabamaArizonaCaliforniaConnecticutIllinoisIndianaLouisianaMassachusettsMarylandMichiganNorth CarolinaNew HampshireNew JerseyOhioTexasUtah
Questions about this recall
Why was it 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 lots are affected?
UDI-DI: 00190376228037, Lot: EM50715
Where was it sold?
US Nationwide distribution in the states of CT, IN, TX, LA, OH, AL, NH, MA, NC, AZ, MD, NJ, IL, CA, UT, MI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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