FDA-Device2018-03-21Class II
36MM COCR MODULAR HD -6MM
Zimmer Biomet, Inc.
Hazard
One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field.
Sold states
Outside USA
Affected count
23
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
36MM COCR MODULAR HD -6MM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1008-2018Don't want to check this manually?
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