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Ossur H / F FDA Recalls
7 recalls on file across devices, 0 of them Class I and 7 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101Class IIAug 20, 2024Pressure sensitive adhesive hooks attached to the sides of t |
| RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic componentClass IIMar 25, 2024Due to firmware issues with the prosthetic knee, there is th |
| RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic componentClass IIMar 25, 2024Due to firmware issues with the prosthetic knee, there is th |
| RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic componentClass IIMar 25, 2024Due to firmware issues with the prosthetic knee, there is th |
| RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic componentClass IIMar 25, 2024Due to firmware issues with the prosthetic knee, there is th |
| Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002Class IIDec 26, 2023Knee batteries may need replacement with conforming batterie |
| Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; IcelockClass IIMay 12, 2023A mechanical lock used to connect and release a locking line |