The Recall Desk
ModerateFDA (Devices)·Z-1573-2022·Announced 2022-08-31

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.

What this means for you

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
Category
Medical Device — Surgical Instruments
Hazard
  • mis-labeling

Distribution

Distributed nationwide across the United States.

Related recalls

Same category