FDA Device recall Z-1621-2013
Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30
- FDA Device
- Class II
- terminated
- Published 2013-07-10
On 2013-07-10 the FDA classified a Class II recall of Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30 by Zimmer, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1621-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-23 |
| Published | 2013-07-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Item Number 00-4305-019-30 with Lot Numbers 61557761, 61591732, 61612275, 61614764, and 77000186. 2010 Market Withdraw…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1621-2013%22
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