Recall Z-1821-2022 ยท ISW Assembly, Knee/Shank/Ankle/Foot, External
Ossur Americas
OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T
| Date | Sep 28, 2022 (initiated Aug 29, 2022) |
| Status | Open, Classified |
| Reason | Battery may dislodge from the Power Knee |
| Root cause | Device Design |
| Action | On 08/29/2022, The firm sent via email an "URGENT MEDICAL DEVICE CORRECTION" Letter informing customers that reports have been received of units where the battery dislodged from the Power Knee units, causing loss of power to the device. This may cause an increase risk for stumbles or falls, potentially leading to an injury. Customer are being instructed to implement a correction to retrofit a security tab to their units. The retrofit kit will be provided with clear instructions for attaching the security tab to the device. In addition, customer are asked to: 1. Pass this notice to those wh |
| Quantity | 190 devices |
| Distribution | U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IA, IL, IN, LA, MA, MD, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, VA, VT, WA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.