DePuy Mitek, Inc., a Johnson & Johnson Co.: Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.

Agency Publication Date: January 15, 2016

Affected Products

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.

Lot Number: M1505055

Lot Numbers:

Number

Product: FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.

Lot Number: M1505053

Lot Numbers:

Number

Product: FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.

Lot Number: M1505056

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 72697

Status: Resolved

Manufacturer: DePuy Mitek, Inc., a Johnson & Johnson Co.

Manufactured In: United States

Units Affected: 3 products (50 units; 45 units; 115 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

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.

Lot Number: M1505055

Lot Numbers:

Number

Product: FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.

Lot Number: M1505053

Lot Numbers:

Number

Product: FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.

Lot Number: M1505056

Lot Numbers:

Number