Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
Reported: July 10, 2013 Initiated: May 23, 2013 #Z-1620-2013
Product Description
Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
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.
Details
- Recalling Firm
- Zimmer, Inc.
- Units 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.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.. Recalled by Zimmer, Inc.. Units affected: 722 units (includes 2010 market withdrawal).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2013. Severity: Moderate. Recall number: Z-1620-2013.
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