The Recall Desk

FDA (Devices) recall action 72697

DePuy Mitek, Inc., a Johnson & Johnson Co. recalled 3 products on 2016-01-27

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2016-01-27
Critical
0
Units
210

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2016-01-27

    DePuy Mitek Recalls FMS neXtra 3.5mm Aggressive Cutter Shaver Blades

    DePuy Mitek is recalling 45 units of FMS neXtra 3.5mm Aggressive Cutter Shaver Blades because the blade configuration does not match the label description.

    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.
    Category
    Distribution
    4 states
  • ModerateFDA (Devices)··2016-01-27

    DePuy Mitek Recalls FMS neXtra 3.5mm Cutter Shaver Blades Due to Labeling Error

    DePuy Mitek is recalling FMS neXtra 3.5mm Full Radius Cutter Shaver Blades because the blade configuration does not match the label description.

    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.
    Category
    Distribution
    4 states
  • ModerateFDA (Devices)··2016-01-27

    DePuy Mitek Recalls FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades

    DePuy Mitek is recalling 115 units of FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades because the blade configuration does not match the label description.

    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.
    Category
    Distribution
    4 states