Comprehensive Reverse Shoulder System Humeral Tray Model 115340
Reported: February 22, 2017 Initiated: December 20, 2016 #Z-1103-2017
Product Description
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
Reason for Recall
Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 4388
- Distribution
- Nationwide. CANADA AUSTRALIA CHILE COLOMBIA KOREA Netherlands
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Comprehensive Reverse Shoulder System Humeral Tray Model 115340. Recalled by Zimmer Biomet, Inc.. Units affected: 4388.
Why was this product recalled? ▼
Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 22, 2017. Severity: Critical. Recall number: Z-1103-2017.
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