Vitality¿ Spinal Fixation System — Class II medical device recall Z-0866-2019
Terminated recall by Zimmer Biomet Spine Inc., reported 2019-03-06, distributed nationwide. The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws,
| Recall number | Z-0866-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet Spine Inc., Westminster, CO, United States |
| Recall initiated | 2018-07-30 |
| Classified | 2019-02-22 |
| Reported by FDA | 2019-03-06 |
| Terminated | 2021-04-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 16,429 devices |
| UPC / GTIN / UDI-DI | 00889024003187 |
Product
Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (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
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-0866-2019. 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.