# FDA recall Z-1182-2024

> **Alphatec Spine, Inc.** · Class II · device recall initiated 2024-01-26.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1182-2024
- **Recalling firm:** Alphatec Spine, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-26
- **Report date:** 2024-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1182-2024

## Citation

> AI Analytics. FDA recall Z-1182-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1182-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*