The Recall Desk
SevereFDA (Devices)·Z-0335-2022·Announced 2021-12-15

OsteoMed Surgical Consoles Recalled for Electrical Safety Violations

OsteoMed OsteoPower Power Consoles and footswitches are being recalled due to non-compliance with electrical safety standard IEC 60601. The product has shocked a patient, creating a significant electrical hazard.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II medical device recall with a reported electrical shock injury to a patient. Non-compliance with electrical safety standard IEC 60601 resulted in actual patient harm, meeting the criterion for Severe classification.

Plain-English summary

OsteoMed is recalling specific models of OsteoPower Power Consoles and D-Power Control Consoles, along with associated footswitches. The recalled products include multiple console variants and footswitch models. Approximately 533 consoles and 586 footswitches have been distributed worldwide.

The consoles do not comply with electrical safety standard IEC 60601. Due to this non-compliance, the product has caused a patient to receive an electrical shock, creating a significant electrical hazard to users and operators.

Affected devices have been distributed throughout the United States, Guam, and internationally to countries including Canada, Mexico, United Kingdom, Germany, Spain, Italy, Japan, and others.

Customers and healthcare facilities in possession of these devices should immediately discontinue use and contact OsteoMed, LLC for return or replacement instructions. Users should verify their device model numbers and serial numbers against the official recall notice.

The recalled product

Product
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Conso
Manufacturer
Osteomed, LLC
Category
Medical Device — Surgical Equipment
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 40 states specifically:

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