# FDA recall Z-2050-2026

> **Centinel Spine, Inc.** · Class II · device recall initiated 2026-03-20.

## Product

Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5    Total cervical disc replacement.

## Reason for recall

Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.

## Distribution

US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.

## Key facts

- **Recall number:** Z-2050-2026
- **Recalling firm:** Centinel Spine, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-20
- **Report date:** 2026-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Chester, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2050-2026

## Citation

> AI Analytics. FDA recall Z-2050-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2050-2026. Source: US FDA. Licensed CC0.

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