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

Recall Z-0794-2019 — Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW

U.S. FDA — Device Enforcement · United States · 2018-11-16 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0794-2019
Date of alert
2018-11-16
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Ascension Orthopedics, Inc
Product category
device
Product type
Devices
Reported risk: The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).
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.

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