Data Foundry

Medical device recalls 2024

IdentiTi ALIF Standalone Interbody System: Part Number/Description… — Class II medical device recall Z-1182-2024

Ongoing recall by Alphatec Spine, Inc., reported 2024-03-06, distributed nationwide. Due to reports of intraoperative graft bolt implantation breakages.

Recall numberZ-1182-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmAlphatec Spine, Inc., Carlsbad, CA, United States
Recall initiated2024-01-26
Classified2024-02-23
Reported by FDA2024-03-06
DistributedNationwide (US)
Countries outside the USNZ
Quantity12,777 devices
UPC / GTIN / UDI-DI00190376299716, 00190376299730, 00190376299754, 00190376299792, 00190376299815, 00190376299839, 00190376369976, 00190376369990, 00190376370019, 00190376370293, 00190376370316, 00190376370330
Lot numbers132-10-85-250, 132-10-85-300, 132-10-85-350, 132-10-90-250, 132-10-90-300, 132-10-90-350, 232-10-85-250, 232-10-85-300, 232-10-85-350, 232-11-90-250, 232-11-90-300, 232-11-90-350, 6746713, 8746709, 8746710, 8746711, 8746712, 8746714, 8746724, 8746725, TO00212, TO00213, TO00218, TO00373, TO00376, TO00380, TO00381, TO00382, TO00383, TO00670, TO00671, TO00672, TO00673, TO00674, TO00694, TO00695, TO00696, TO00697, TO00698, TO00699 and 44 more

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.

Reason for recall

Due to reports of intraoperative graft bolt implantation breakages.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1182-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.