Zimmer Biomet, Inc. recalls Comprehensive Reverse Shoulder System Humeral Tray Model 115340
- Recall date
- December 20, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1103-2017
- FDA classification
- Class I
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- Nationwide. CANADA AUSTRALIA CHILE COLOMBIA KOREA Netherlands
Why it was recalled
Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
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