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…
Read the official notice →- Date
- 2024-01-31
- Country
- United States
- Brand
- Ossur H / F
- Product
- Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
- Classification
- Class II
- Units
- US Nationwide distribution including in the states of MA, SC, MD, TN, ND, VA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 →- 2024-05-22
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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 → - 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
- 2024-01-31
- US
Philips North America recalls Achieva 3.0T, Model No. 781177
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the…
FDA · DevicePhilips North AmericaWorldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS,…Official notice → - US
C.R. Bard Inc recalls Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- US
KENT IMAGING, INC. recalls Snapshot NIR, REF: KD204
Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
FDA · DeviceKENT IMAGING, INC.Worldwide - US Nationwide distribution in the states of IN, OH, TX, PA, WI,…Official notice → - US
Beckman Coulter, Inc. recalls Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
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Phadia Ab recalls EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen.
- US
Hologic, Inc. recalls PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps…
Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
FDA · DeviceHologic, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AR,…Official notice →