Recall Z-0788-2024 ยท ISW Assembly, Knee/Shank/Ankle/Foot, External
Ossur H / F
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
| Date | Jan 25, 2024 (initiated Dec 26, 2023) |
| Status | Open, Classified |
| Reason | Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may experience loss of support that can lead to a fall and potential injury. |
| Root cause | Process control |
| Action | On 12/26/23, recall notices were mailed to customers who were asked to do the following: a. Check the serial number of the Power Knee Batteries to confirm the affected units. b. Replace the affected batteries with the new batteries supplied along with this letter. c. To ensure future traceability, please fit each new battery into the designated knee according to the knee Serial Number indicated on the sticker on the back of the battery. d. PASS THIS NOTICE to those who need to be aware within your organization. If you have further distributed this product, please identify your customers, and |
| Quantity | 544 Batteries |
| Distribution | US Nationwide distribution including in the states of MA, SC, MD, TN, ND, VA, IL, NJ, FL, MI, NY, AL, TX, OK, IN, GA, CA, PA, NM, VT, NV, MS, HI, OH, WI, LA, IA, NE, MN, AR, OR, NC, NH, WV, CO, ID, AZ, MO, CT, WA, KY, UT, KS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.