FDA-Device2018-03-21Class II
Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
Zimmer Biomet, Inc.
Hazard
Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box.
Sold states
US Nationwide in the states of MN, NJ, CA, TX, ND
Affected count
12
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0979-2018Don't want to check this manually?
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