# FDA recall Z-0868-2019

> **Zimmer Biomet Spine Inc.** · Class II · device recall initiated 2018-07-30.

## Product

Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation  (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications

## Reason for recall

The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications

## Distribution

Distributed Nationwide: AL, CA, CO, FL, GA, HI, IA, ID, IL, IN, LA, MA, MD, MI, MN, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, WA and  WI.**** International distribution: Australia and EMEA.

## Key facts

- **Recall number:** Z-0868-2019
- **Recalling firm:** Zimmer Biomet Spine Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-30
- **Report date:** 2019-03-06
- **Termination date:** 2021-04-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Westminster, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0868-2019

## Citation

> AI Analytics. FDA recall Z-0868-2019. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0868-2019. Source: US FDA. Licensed CC0.

---

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