Recall archive
8 recalls · page 1 of 1
Reported Oct 9, 2024
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ossur H / F
Matched: Brand — Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which…
FDA (openFDA device enforcement)
Reported May 22, 2024
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ossur H / F
Matched: Brand — Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 31, 2024
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ossur H / F
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Jun 21, 2023
Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ossur H / F
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Apr 27, 2016
Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ossur H / F
Matched: Brand · Product · Product details — There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 6, 2016
Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an accessory used with the knee braces to provide…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ossur H / F
Matched: Brand · Reason for recall — Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage…
13 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 1, 2015
The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ossur H / F
Matched: Brand — The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released…
FDA (openFDA device enforcement)
Reported Mar 25, 2015
LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ossur H / F
Matched: Brand — The threads of the outer tube of the shock module of LP Rotate are too short, resulting in insecure assembly. Use of the product may cause the…
FDA (openFDA device enforcement)
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