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DePuy Mitek, Inc., a Johnson & Johnson Co. recalls FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, sha
Recalled January 27, 2016 · FDA recall Z-0656-2016 · DePuy Mitek, Inc., a Johnson & Johnson
Hazard
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label. · FDA Class II
Units
50 units
Sold at
Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.
Description
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Product
FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Manufacturer(s)
DePuy Mitek, Inc., a Johnson & Johnson Co.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →