Recall Z-0492-2014— Aesculap, Inc.

Name: FDA recall Z-0492-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-19

Class II · Terminated

Class II FDA medical device recall by Aesculap, Inc., initiated 2013-09-19, terminated 2014-12-22. It names 2 FDA 510(k) clearances: K122985, K083772. Product: Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7. Reason: The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible..

Recalling firm: Aesculap, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-09-19
Terminated: 2014-12-22
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K122985 — COLUMBUS REVISION KNEE SYSTEMAesculap Implant System, Inc.·cleared 2012-10-26
K083772 — COLUMBUS REVISION KNEE SYSTEMAesculap Implant System, Inc.·cleared 2009-06-04

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

Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7

Reason for recall

The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible.

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