FDA Medical Device Recalls (openFDA)
Zimmer, Inc.: 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.
- Recall number
- Z-1620-2013
- Recalling firm
- Zimmer, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2013-05-23
- Posted
- 2013-07-01
- Terminated
- 2014-12-18
- 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.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- Item Number: 00-4305-019-40 with Lot Numbers 61588143 and 61612276. 2010 Market Withdrawal: Item #:430501940 Lot #'s: 60768814, 60806551, 60893241, 60946820, 60999665, 61031668, 61110808, 61170678, 61205673, 61244194, 61392456, 61430127
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28