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 number | Z-1182-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alphatec Spine, Inc., Carlsbad, CA, United States |
| Recall initiated | 2024-01-26 |
| Classified | 2024-02-23 |
| Reported by FDA | 2024-03-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | NZ |
| Quantity | 12,777 devices |
| UPC / GTIN / UDI-DI | 00190376299716, 00190376299730, 00190376299754, 00190376299792, 00190376299815, 00190376299839, 00190376369976, 00190376369990, 00190376370019, 00190376370293, 00190376370316, 00190376370330 |
| Lot numbers | 132-10-85-250, 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.