Recall Z-0335-2022 ยท KMW Handpiece, Rotary Bone Cutting
Osteomed, LLC
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 450-0
| Date | Oct 28, 2021 |
| Status | Open, Classified |
| Reason | Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient. |
| Root cause | Device Design |
| Action | 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) Revi |
| Quantity | 533 consoles and 586 footswitches |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, Guam, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and WI. The countries of Argentina, Bolivia, Brazil, Canada, Chile, Colo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971692 | OSTEOPOWER SYSTEM AND ACCESSORIES Osteomed Corp., Jun 27, 1997 |