DePuy Mitek, Inc., a Johnson & Johnson Co.: Medical Device Recall in 2016 - (Recall #: Z-0657-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 20, 2015

Date Posted: January 27, 2016

Recall Number: Z-0657-2016

Event ID: 72697

Reason for Recall:

Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.

Status: Terminated

Product Quantity: 45 units

Code Information:

Lot Number: M1505053

Distribution Pattern:

Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.

Voluntary or Mandated:

Voluntary: Firm initiated