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, shavin…
- Recall date
- November 20, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0656-2016
- FDA classification
- Class II
- Brand / firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Sold / distributed
- Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.
Why it was recalled
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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