FDA recall record · openFDA

Ossur H / F

7 FDA recalls on record (2023–2024) — 7 device. 7 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown whic 4

Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or 1

A mechanical lock used to connect and release a locking liner into a prosthetic socket have an attachment pin and lock t 1

Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally 1

Recalls

RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component Class II 2024-03-25 RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component Class II 2024-03-25 RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component Class II 2024-03-25 RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component Class II 2024-03-25 Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101 Class II 2024-08-20 Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002 Class II 2023-12-26 Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock Class II 2023-05-12

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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