Recall Z-1703-2018— DePuy Orthopaedics, Inc.

Name: FDA recall Z-1703-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-16

Class II · Terminated

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2018-04-16, terminated 2019-04-02. It names one FDA 510(k) clearance: K160700. Product: ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee. Reason: There may be burrs on the extraction hole threads..

Recalling firm: DePuy Orthopaedics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-04-16
Terminated: 2019-04-02
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K160700 — ATTUNE Revision Knee SystemDepuy(Ireland)·cleared 2016-06-10

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

ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee

Reason for recall

There may be burrs on the extraction hole threads.

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