Bigliani/Flatow The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30. Used in retracting the humeral

FDA device recall Z-1621-2013 · posted 2013-07-01 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

This is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included. Zimmer, Inc. is initiating a recall of small and large Fukuda-type retractors due to fractures occurring at the grooves around the perimeter of the blades while being used during surgery.

Action taken

In 2010, Zimmer initiated a recall of the Bigliani/Flatow Fukuda Retractors due to fractures occurring at the grooves around the perimeter of the blades. Zimmer is expanding this recall to include seven lots that were not previously included. On 5/23/13, an Urgent Medical Device Recall notification letter went to all consignees explaining the recall expansion and risk associated with the recall. All consignees are to locate and quarantine the device immediately. Please return the product along with the completed inventory certification form to Zimmer. If you have any questions regarding this recall, call Zimmer at 877-946-2761.

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

722 units (includes 2010 market withdrawal)

Distribution

Worldwide Distribution-USA (nationwide) including the states of NY, MI, MN, OH, IN, IL, VA, MD, PA, WA, KY, CT, RI, NH, TX, MT, and CA and the countries of Chile, China, South Korea, and Australia.

Date initiated

2013-05-23

Date posted

2013-07-01

Date terminated

2014-12-18

Location

Warsaw, IN