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

Recall Z-1103-2017 — Comprehensive Reverse Shoulder System Humeral Tray Model 115340

U.S. FDA — Device Enforcement · United States · 2016-12-20 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1103-2017
Date of alert
2016-12-20
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Zimmer Biomet, Inc.
Product category
device
Product type
Devices
Reported risk: Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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