High FDA (Devices)·Z-0810-2013·Announced 2013-02-20

Mizuho Orthopedic Table Spar Recall Due to Possible Instability

Mizuho OSI is recalling 869 orthopedic table spars because a failed epoxy bond could cause the aluminum plug to migrate, potentially compromising table stability.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device that could lead to instability and potential harm, but the source text does not report any injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Mizuho OSI is recalling 869 units of the Mizuho Orthopedic Table, model 5855, specifically the sub assembly 5855-901 Orthopedic Table Spar. These devices were manufactured between 1996 and 2007 and distributed worldwide, including in the United States and various international markets.

The recall is issued due to a possible instability of the Orthopedic Table Top. If the epoxy bond fails, the aluminum plug may migrate out of the carbon fiber tube. This failure could require the replacement of the Orthopedic Table Spar to ensure the stability of the table top.

The source text does not specify specific actions for consumers or healthcare facilities beyond the implication that the spar may need to be replaced to ensure stability. No injuries or illnesses are reported in the source text.

The recalled product

Product: Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
Manufacturer: Mizuho OSI
Category: Medical Device — Surgical Tables
Hazard: structural-failure
instability
Affected units: 869

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 (3)

Table model 5855
sub assembly 5855-901 Orthopedic Table Spar
manufactured between 1996 and 2007.

Distribution

Distributed in 48 states:

Same manufacturer · Mizuho OSI

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