Mizuho OSI Femoral Hooks Recalled for Incorrect Model Etching
Mizuho OSI is recalling one batch of regular femoral hooks that were etched with an incorrect model designation. The recalled batch contains 13 devices distributed in the United States and Canada.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II medical device recall involves a labeling error. One batch of regular femoral hooks were incorrectly etched with a classic model designation. No illnesses, injuries, or clinical consequences have been reported.
Plain-English summary
Mizuho OSI is recalling a batch of regular femoral hooks that were mistakenly etched with a classic model number designation. The hooks should have been marked as regular model, but were instead etched with the classic femoral hook model number.
The recalled devices were distributed nationwide in the United States, including California, Florida, Georgia, Michigan, Nebraska, New Jersey, Tennessee, Utah, and Washington, as well as Canada. The affected batch is identified as lot number MIZ210712 and comprises 13 devices.
The incorrect etching creates potential for model identification confusion, as users may be uncertain about the correct device designation. Healthcare providers and other users who have received devices from this batch should contact Mizuho OSI to determine if their femoral hooks are part of this recall and to receive guidance on appropriate next steps.
The recalled product
- Product
- HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
- Manufacturer
- Mizuho OSI
- Hazard
- Affected units
- 13
Distribution
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