Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002

FDA device recall Z-0788-2024 · posted 2024-01-25 · Open, Classified

Recall details

Recalling firm

Ossur H / F

Reason for recall

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.

Action taken

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 notify them at once of this product alert. We recommend that you include a copy of this notice. e. Complete and return acknowledgement forms and affected batteries in pre-paid return packaging provided. Customers with questions can contact customer service at 1-800-233-6263, extension 10

Root cause

Process control

Status

Open, Classified

Product code

ISW

Quantity affected

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

Date initiated

2023-12-26

Date posted

2024-01-25

Location

Reykjavik, Iceland