# FDA recall Z-0196-2023

> **Alphatec Spine, Inc.** · Class II · device recall initiated 2022-09-14.

## Product

Disc Preparation instruments contained in the following products:  CI-11050-08102515  Longer IdentiTi PO Trial Tip, 11A X 8P X 10 X 25mm, 15¿  TC11050  00840180510810    CI-11050-09102515  Longer IdentiTi PO Trial Tip, 12A X 9P X 10 X 25mm, 15¿  TC11050  00840180510827    CI-11050-10102515  Longer IdentiTi PO Trial Tip, 13A X 10P X 10 X 25mm, 15¿  TC11050  00840180510834    CI-11050-11102515  Longer IdentiTi PO Trial Tip, 14A X 11P X 10 X 25mm, 15¿  TC11050  00840180510841    CI-11050-12102515  Longer IdentiTi PO Trial Tip, 15A X 12P X 10 X 25mm, 15¿  TC11050  00840180510858    CI-11051-10-07  Longer Rotating Disc Shaver, Parallel, 7mm  TC11051  00840180511084    CI-11051-20-13  Longer Rotating Disc Shaver, Parallel, 13mm  TC11051  00840180511145    CI-11051-20-15  Longer Rotating Disc Shaver, Parallel, 15mm  TC11051  00840180511169    CI-11051-20-09  Longer Rotating Disc Shaver, Parallel, 9mm  TC11051  00840180511107    CI-11051-20-08  Longer Rotating Disc Shaver, Parallel, 8mm  TC110

## Reason for recall

Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing.

## Distribution

U.S.: CA  O.U.S.: N/A

## Key facts

- **Recall number:** Z-0196-2023
- **Recalling firm:** Alphatec Spine, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-14
- **Report date:** 2022-11-16

- **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-0196-2023

## Citation

> AI Analytics. FDA recall Z-0196-2023. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0196-2023. Source: US FDA. Licensed CC0.

---

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