Z-1620-2013Class II

Bigliani/Flatow The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the...

Name: Z-1620-2013 Bigliani/Flatow The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the...
Creator: Zimmer, Inc.
Published: 2013-05-23
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-05-23 / Terminated / root cause: design

FDA source

Zimmer, Inc. began a recall of Bigliani/Flatow The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire... on 2013-05-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1620-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-23
Posted: 2013-07-01
Terminated: 2014-12-18
Recalling firm: Zimmer GmbH
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.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1620-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1620-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1621-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)