Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0868-2019 — 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 thread

U.S. FDA — Device Enforcement · United States · 2018-07-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0868-2019
Date of alert: 2018-07-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zimmer Biomet Spine Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00889024003187

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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