Agency classClass IIOur severity:Severe FDA (Devices)·Z-1621-2013·Announced 2013-07-10

Zimmer Recalls Fukuda Retractors Due to Fracture Risk During Surgery

Zimmer, Inc. is recalling Fukuda-type retractors because they may fracture at the grooves during surgical use. This recall expands a 2010 action to include seven additional lots.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (fractures) in a medical device used during surgery, which meets the criteria for a Severe rating due to the risk of significant injury.

Plain-English summary

Zimmer, Inc. is initiating a recall of small and large Fukuda-type retractors. The recall is being conducted because fractures have occurred at the grooves around the perimeter of the blades while the devices were being used during surgery.

This action is an expansion of a 2010 recall and now includes seven additional lots that were not previously included. The specific product identified is the Bigliani/Flatow The Complete Solution Fukuda Retractors Small Nonsterile, Item Number 00-4305-019-30. The affected units are used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.

The recall covers 722 units, which includes units from the 2010 market withdrawal. Distribution was worldwide, including nationwide distribution in the United States and in Chile, China, South Korea, and Australia. The affected lots include Item Number 00-4305-019-30 with Lot Numbers 61557761, 61591732, 61612275, 61614764, and 77000186, as well as 2010 Market Withdrawal part numbers with specific lot numbers listed in the source.

The recalled product

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.
Manufacturer: Zimmer, Inc.
Category: Medical Device — Surgical Instrument
Hazard: structural-failure
surgical-injury

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

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

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Zimmer, Inc.

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