Recall Z-0335-2022
Osteomed, LLC · initiated October 28, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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 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
Codes / lots: Product#/Brand Name/UDI Code: 450-0005-00 / OsteoMed OsteoPower Power Console 2i / 0084569401211 450-0021-00 / OsteoMed OsteoPower Power Console 2 / 0084569401215 450-0390 / OsteoMed BMF Footswitch / 0084569401215 450-0005-01 / OsteoMed D-Power Control Console 2i / 0084569401211 450-0021-01 / OsteoMed D-Power Control Console 2 / 0084569401211 ECOS-450-0021-00 / Power Control Console 2 / 0084569401211 ECOS-450-0005-00 / Power Control Console 2i / 0084569401211 Serial Numbers: 0332004 450-0005-01 0422006 450-0005-00 0423001 450-0005-01 0434003 S 0434004 S 0434010 S 0443004 0423005 450-0005-01 0449004s 0509004S 0509005S 0506027 0445003 0445005 9912003 0515009 0525014 0532001 0521042 0521045 0535006 0535007 0537031 0537032 0537033 0537034 0540005 0547022 0551022 0551025 0552008 0552009 0611004 0604070 0616001 0616002 0615005 0615009 0615010 0615039 0616003 0616005 0615041 0620004 0620005 0622022 0622023 0633024 0641004 0643068 0645002 0645003 0641009 0648023 0648025 0649002 0649003 0701004 0702021 0701005 0640004 0701006 0701009 0704036 0651097 0714001 0714002 0715029 0715031 0715032 0718003 0719005 0722041 0727024 0727025 0721005 0729044 0734030 0738015 0738017 0740001 0743032…
Reason for recall
Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
FDA-determined cause: Device Design
Action taken
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: RecallNotificationGroup@acumed.net 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 kathryn.jayne@acumed.net RecallNotificationGroup@acumed.net
Details
- Recall number
- Z-0335-2022
- Initiated
- October 28, 2021
- Product code
- KMW – Handpiece, Rotary Bone Cutting
- 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, Colombia, Dominican Republic, Ecuador, Germany, Guatemala, Indonesia, Italy, Japan, Korea, Kuwait…
- Recalling firm
- Osteomed, LLC, Addison, TX