Recall Z-0658-2016— DePuy Mitek, Inc., a Johnson & Johnson Co.

Name: FDA recall Z-0658-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-20

Class II · Terminated

Class II FDA medical device recall by DePuy Mitek, Inc., a Johnson & Johnson Co., initiated 2015-11-20, terminated 2017-04-12. It names one FDA 510(k) clearance: K954465. 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.. Reason: Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label..

Recalling firm: DePuy Mitek, Inc., a Johnson & Johnson Co.
Classification: Class II
Status: Terminated
Initiated: 2015-11-20
Terminated: 2017-04-12
Firm location: Raynham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K954465 — FMS DUOFuture Medical Systems, Inc.·cleared 1995-11-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.