FDAFDA · Food and drugs·Recall number Z-1621-2013
Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
Published July 10, 2013 · Recall initiated: May 23, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- 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.
- Lot
- Item Number 00-4305-019-30 with Lot Numbers 61557761, 61591732, 61612275, 61614764, and 77000186. 2010 Market Withdrawal part numbers: Item #:430501930, Lot#s: 60795817, 60834923, 60916795, 60997103, 61017041, 61038697, 61075510, 61128521, 61186400, 61199809, 61253702, 61392455, 61430126
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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