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 Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.

On 10/28/2021, the firm initiated a telephone communication and sent an "URGENT Medical Device Recall" communication/letter informing customers that the Power Consoles and Footswitches do not meet the current electrical and safety testing requirements for medical devices per IEC 60601 and as such, could result in possible electrical shocks to patients and users and potentially cause interference with other devices. Customer are instructed to: 1) Immediately discontinue use of devices by powering off, unplug the device and move the device to a separate room away from the point of care. 2) Review the Notification letter in full, review current inventory, and complete and return the Acknowledgement and Receipt Form via email or fax within the 7 calendar days. Fax: 972.677.4766 Email: [email protected] 3) Return devices within the scope of the recall and unused consumable inventory and 4) immediately discontinuing use of the devices within the scope of this voluntary recall. OsteoMed will provide FedEx shipping account information. In addition, we have issued a Return Material Authorization specific to your facility. This is located on the Acknowledgement and Receipt Form. 5) Distributors are being notified of this recall and involved in the communication. Distributors are requested to send their devices back with the RMA provided. The Recalling Firm is: initiated this voluntary recall and is requesting that all affected units be removed from point of care to prevent use of the device. The Recalling Firm will provide return information and point of care destruction should customers opt to dispose of the device at their facilities. For any questions, contact: Monday-Friday, 8 AM 5 PM CDT Kathryn A. Jayne Sr. Director, Quality Assurance &Regulatory Affairs OsteoMed LLC 972.677.4766 [email protected] [email protected]