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

Recall Z-1350-2021 — NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 180 mm length; Orthopedic trauma intramedullary rod

U.S. FDA — Device Enforcement · United States · 2021-02-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1350-2021
Date of alert: 2021-02-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Nuvasive Specialized Orthopedics Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00812258022730

Reported risk: Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.

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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