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.
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 3/5 (High).
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
- 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
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