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.
Read the official notice →- Date
- 2024-05-22
- Country
- United States
- Brand
- Ossur H / F
- Product
- RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, HI,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Ossur H / F recalls
- 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 →- 2024-01-31
- 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 →
Other drugs & medical recalls in the United States
- 2024-05-22
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Namic FLUID DELIVERY SET, REF 91300040
Products have a lack of sterility assurance.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC,…Official notice → - US
- US
TriMed Inc. recalls TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref:…
Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
FDA · DeviceTriMed Inc.US Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IL, LA,…Official notice → - US
Boston Scientific Corporation recalls Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material…
FDA · DeviceBoston Scientific CorporationWorldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia…Official notice → - US
Pharma Nobis LLC recalls Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free Grape, 10 fl. oz bottle, Distributed by: Meijer Distribution…
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
- US
Sagent Pharmaceuticals recalls MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for…
Presence of Particulate Matter: Potential for black particulates in the drug product.