Z-1621-2013 Class II Terminated
FDA device recall Z-1621-2013 was initiated by Zimmer, Inc. on May 23, 2013 and is designated Class II. 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… The recall status is terminated (terminated Dec 18, 2014). Affected quantity: 722 units (includes 2010 market withdrawal).
Recall Details
- Product Type
- Devices
- Report Date
- Jul 10, 2013
- Initiation Date
- May 23, 2013
- Termination Date
- Dec 18, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 722 units (includes 2010 market withdrawal)
Product Description
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.
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.
Distribution Pattern
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.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1621-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026