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Terminated

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

FDA Recall Z-0492-2014 · Posted 2013-12-13

Recalling FirmAesculap, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2013-09-19
Date Terminated2014-12-22
Product Quantity24

Reason for Recall

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

Firm Action

Domestic consignees were contacted by phone and a recall notification letters was also sent to these Users on/about September 26, 2013.

Root Cause

Component change control

Distribution Pattern

Distributed in FL and MD.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122985COLUMBUS REVISION KNEE SYSTEMAesculap Implant System, Inc. · 2012-10-26K083772COLUMBUS REVISION KNEE SYSTEMAesculap Implant System, Inc. · 2009-06-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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