Agency classClass IIOur severity:Severe FDA (Devices)·Z-1620-2013·Announced 2013-07-10

Zimmer Recalls Fukuda Retractors Due to Fractures During Surgery

Zimmer, Inc. is recalling Fukuda retractors because they fracture at the grooves during use. The recall includes 722 units distributed worldwide.

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 surgical instrument, which meets the criteria for a Severe rating due to the risk of significant injury during use.

Plain-English summary

Zimmer, Inc. is recalling small and large Fukuda-type retractors, specifically the Bigliani/Flatow The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. These medical devices are used to retract the humeral shaft posteriorly and expose the glenoid surface during surgery.

The recall is being initiated because fractures have occurred at the grooves around the perimeter of the blades while the devices were being used during surgical procedures. This action is an expansion of a 2010 recall and now includes seven additional lots that were not previously covered.

The recall involves 722 units, including those from the 2010 market withdrawal. The devices were distributed nationwide in the United States and in Chile, China, South Korea, and Australia. Affected lots include 61588143 and 61612276, as well as twelve additional lots from the 2010 withdrawal.

The recalled product

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.
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 (11)

60806551
60893241
60946820
60999665
61031668
61110808
61170678
61205673
61244194
61392456
61430127

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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