Ossur H / F recalls
4 official recalls and safety alerts involving Ossur H / F since 2023-06, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Ossur H / F or the relevant agency.
- 2024-10-09
USOssur H / F recalls Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which may lead to them gradually peeling off with repeated doffing,…
FDA · DeviceOssur H / FUS: NH, MA, NY, NJ, PA, GA, MD, NC, IN, FL, AR, TN, KY, OH, MI, IL, TX, MO,…Official notice →- 2024-05-22
- US
Ossur H / F recalls RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
FDA · DeviceOssur H / FUS Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, HI,…Official notice → - 2024-01-31
- US
Ossur H / F recalls Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
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…
FDA · DeviceOssur H / FUS Nationwide distribution including in the states of MA, SC, MD, TN, ND, VA,…Official notice → - 2023-06-21
- US
Ossur H / F recalls Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption…
A mechanical lock used to connect and release a locking liner into a prosthetic socket have an attachment pin and lock that can wear down faster than expected, leading to the potential for the pin to disengage from the…
FDA · DeviceOssur H / FUS: SC, FL,NM, PA, VA, CA, TX, MT, UT, OH, NV, KS, MI, GA, IA, WA, TN, AZ, MN,…Official notice →