Z-1182-2024Class II

IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft...

Name: Z-1182-2024 IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft...
Creator: Alphatec Spine, Inc.
Published: 2024-01-26
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2024-01-26 / Open, Classified / root cause: design

FDA source

Alphatec Spine, Inc. began a recall of 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... on 2024-01-26. FDA classified it as Class II and gives the reason as "Due to reports of intraoperative graft bolt implantation breakages". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1182-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-26
Posted: 2024-02-23
Recalling firm: Alphatec Spine, Inc.
Product: 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.
Product code: OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Reason for recall: Due to reports of intraoperative graft bolt implantation breakages.
Root cause tag: design
FDA root cause: Device Design
Action: On 01/26/2024, the firm emailed an "URGENT-MEDICAL DEVICE RECALL NOTIFICATION" Letter to customer informing them that, The Surgical Technique Guide, LIT-85141, and Instructions for Use, INS-130, were revised to require hole preparation prior to insertion of an IdentiTi SA Graft Bolt, as well as to add a new caution statement, to confirm with fluoroscopy that the graft bolt insertion angle is as close as possible to a 40-degree trajectory. The revised labeling mitigates potential fracturing of the Graft Bolt intra-operatively or post-operatively. Customer are instructed to: Please share this notice with all of those who need to be aware within your organization or any organization where the affected product has been transferred. - Inform doctors and surgical staff of the labeling (surgical technique and instructions for use) - Please fill out the last page of this letter to confirm that you have read this notification and will complete the necessary actions as described in this notification. - If you have any questions/concerns or require assistance with the correction, please contact by e-mailing [email protected] or calling 1-800-922-1356.
Quantity in commerce: 12,777 devices
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1182-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1182-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-23

Product code OVD

K232097Class IIIdentiTi ALIF Interbody SystemsAlphatec Spine, Inc. / cleared 2023-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)