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…
Read the official notice →- Date
- 2023-06-21
- Country
- United States
- Brand
- Ossur H / F
- Product
- Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption…
- Classification
- Class II
- Units
- US: SC, FL,NM, PA, VA, CA, TX, MT, UT, OH, NV, KS, MI, GA, IA, WA, TN, AZ, MN,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- US
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 → - 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 →
Other drugs & medical recalls in the United States
- 2023-06-21
- US
Howmedica Osteonics Corp. recalls Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size 26mm, +3 Trial Head.
FDA · DeviceHowmedica Osteonics Corp.International distribution in the country of Ireland.Official notice → - US
Merit Medical Systems, Inc. recalls Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
There is a potential that valve assemblies will not open. preventing fluid from draining.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA,…Official notice → - US
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
- US
Remote Diagnostic Technologies Ltd. recalls Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM".
FDA · DeviceRemote Diagnostic Technologies Ltd.US Nationwide distribution in the states of UT, CO, CA, NE, IL, TX, WV, KS, GA.Official notice → - US
New Standard Device Inc recalls 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
The threads on posts stripping out when tensioned during application process.
FDA · DeviceNew Standard Device IncU.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.Official notice → - US
Apothecary Products, LLC recalls Eye and Ear Dropper, Product Code 67082
Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb.
FDA · DeviceApothecary Products, LLCWorldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO,…Official notice →