FDA-Device2016-01-27Class II
FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
DePuy Mitek, Inc., a Johnson & Johnson Co.
Hazard
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Sold states
Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.
Affected count
45 units
Manufactured in
325 Paramount Drive, N/A, Raynham, MA, United States
Products
FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0657-2016Don't want to check this manually?
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