CLASS II ONGOING Device recall · Reported 6 Mar 2024 · FDA Enforcement Report

IdentiTi ALIF Standalone Interbody System recalled by Alphatec Spine

Alphatec Spine is recalling IdentiTi ALIF Standalone Interbody System, distributed nationwide in the US. The recall was initiated on 26 Jan 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number / Product Description / UDI-DI Code / Lot Number 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm UDI-DI code: 00190376299716 Lot Numbers: 8746709, 8746724, TO00212 132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm UDI-DI code: 00190376299730 Lot Numbers: 8746710, 8746725, TO00213 132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm UDI-DI code: 00190376299754 Lot Numbers: 8746711, TO00218 132-10-90-250 / IdentiTi ALIF SA Graft Bolt, 09 x 25 mm UDI-DI code: 00190376299792 Lot Numbers: 8746712 132-10-90-300 / IdentiTi ALIF SA Graft Bolt, 09 x 30 mm UDI-DI code: 00190376299815 Lot Numbers: 6746713 132-10-90-350 / IdentiTi ALIF SA Graft Bolt, 09 x 35 mm UDI-DI code: 00190376299839 Lot Numbers: 8746714 232-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm UDI-DI code: 00190376369976 Lot Numbers: TO00373, TO00670, TO00694, TO00834, TO01038, TO01404, TO01514, TO01572, TO01573, TO01696, TO01974, TO01979, TO01982, TO02297, TO02393, TO03218, TO03465 232-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm UDI-DI code: 00190376369990 Lot Numbers: TO00376, TO00671, TO00695, TO00710, TO00835, TO01039, TO01405, TO01515, TO01574, TO01575, TO01697, TO01975, TO01980, TO01983, TO02298, TO02394, TO03219, TO03466 232-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm UDI-DI code: 00190376370019 Lot Numbers: TO00380, TO00672, TO00696, TO00836, TO01576, TO01577, TO02163, TO02395 232-11-90-250 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 25 mm UDI-DI code: 00190376370293 Lot Numbers: TO00381, TO00673, TO00697, TO01277, TO01578, TO02396 232-11-90-300 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 30 mm UDI-DI code: 00190376370316 Lot Numbers: TO00382, TO00674, TO00698, TO01040, TO01406, TO02164, TO02397, TO03220 232-11-90-350 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 35 mm UDI-DI code: 00190376370330 Lot Numbers: TO00383, TO00699, TO01407, TO02398

Quantity recalled12,777 devices

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-1182-2024
FDA event ID: 93898
Recalling firm: Alphatec Spine, Carlsbad, CA
Classification: Class II
Status: Ongoing
Recall initiated: 26 Jan 2024
FDA classified: 23 Feb 2024
Reported: 6 Mar 2024
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

26 Jan 2024	Recall initiated by company
23 Feb 2024	Classified by FDA	+28 days
6 Mar 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to reports of intraoperative graft bolt implantation breakages.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm 132-10-90-250 / IdentiTi ALIF SA Graft Bolt, 09 x 25 mm 132-10-90-300 / IdentiTi ALIF SA Graft Bolt, 09 x 30 mm 132-10-90-350 / IdentiTi ALIF SA Graft Bolt, 09 x 35 mm 232-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 232-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 232-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm 232-11-90-250 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 25 mm 232-11-90-300 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 30 mm 232-11-90-350 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 35 mm The IdentiTi ALIF Standalone Interbody System is an integrated intervertebral body fusion device for use in anterior lumbar interbody fusion (ALIF) procedures.

Where it was distributed

Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IN, KS, KY, MD, MI, MN, MS, NC, NH, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, WA and WI. The country of New Zealand.

Nationwide Alabama Arizona California Colorado Connecticut Florida Georgia Iowa Idaho Indiana Kansas Kentucky Maryland Michigan Minnesota Mississippi North Carolina New Hampshire Nevada New York

Questions about this recall

Why was it recalled?

Due to reports of intraoperative graft bolt implantation breakages.

Which lots are affected?

Part Number / Product Description / UDI-DI Code / Lot Number 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm UDI-DI code: 00190376299716 Lot Numbers: 8746709, 8746724, TO00212 132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm UDI-DI code: 00190376299730 Lot Numbers: 8746710, 8746725, TO00213 132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm UDI-DI code: 00190376299754 Lot Numbers: 8746711, TO00218 132-10-90-250 / IdentiTi ALIF SA Graft Bolt, 09 x 25 mm UDI-DI code: 00190376299792 Lot Numbers: 8746712 132-10-90-300 / IdentiTi ALIF SA Graft Bolt, 09 x 30 mm UDI-DI code: 00190376299815 Lot Numbers: 6746713 132-10-90-350 / IdentiTi ALIF SA Graft Bolt, 09 x 35 mm UDI-DI code: 00190376299839 Lot Numbers: 8746714 232-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm UDI-DI code: 00190376369976 Lot Numbers: TO00373, TO00670, TO00694, TO00834, TO01038, TO01404, TO01514, TO01572, TO01573, TO01696, TO01974, TO01979, TO01982, TO02297, TO02393, TO03218, TO03465 232-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm UDI-DI code: 00190376369990 Lot Numbers: TO00376, TO00671, TO00695, TO00710, TO00835, TO01039, TO01405, TO01515, TO01574, TO01575, TO01697, TO01975, TO01980, TO01983, TO02298, TO02394, TO03219, TO03466 232-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm UDI-DI code: 00190376370019 Lot Numbers: TO00380, TO00672, TO00696, TO00836, TO01576, TO01577, TO02163, TO02395 232-11-90-250 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 25 mm UDI-DI code: 00190376370293 Lot Numbers: TO00381, TO00673, TO00697, TO01277, TO01578, TO02396 232-11-90-300 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 30 mm UDI-DI code: 00190376370316 Lot Numbers: TO00382, TO00674, TO00698, TO01040, TO01406, TO02164, TO02397, TO03220 232-11-90-350 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 35 mm UDI-DI code: 00190376370330 Lot Numbers: TO00383, TO00699, TO01407, TO02398

Where was it sold?

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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