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U.S. Department of Health and Human Services

Class 2 Device Recall MISHA Knee System

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 Class 2 Device Recall MISHA Knee Systemsee related information
Date Initiated by FirmDecember 02, 2024
Date PostedDecember 23, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0762-2025
Recall Event ID 95887
Product Classification Medial Knee Implanted Shock Absorber - Product Code QVV
ProductMISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Code Information REF/UDI-DI/Lot(Expiration): 2-1001/00856047005795/23032901(29-Mar-25), 23092102(21-Sep-25), 24032601(26-Mar-26). 2-1002/00856047005801/23032902(29-Mar-25), 23092503(25-Sep-25), 24040801(8-Apr-26).
Recalling Firm/
Manufacturer		 Moximed, Inc.
46602 Landing Pkwy
Fremont CA 94538-6420
For Additional Information ContactMarianne Vlacos
510-887-3385
Manufacturer Reason
for Recall		Knee implant may fracture due to a supplier-related issue with one component that has nonconforming geometry at the distal end of the absorber component that may result in a reduced wall thickness and microcracks, which may lead to new or worsening symptoms of discomfort, swelling / edema, pain or stiffness, which may necessitate removal of the device.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 12/2/2034, recall notices were sent to customers who were asked to do the following: Recipients of implants from the Affected Lots can continue to use their implant as usual. However, you should evaluate patients who present with any new or worsening symptoms of discomfort, swelling / edema, pain or stiffness. If a device issue is suspected or you or your patient is concerned, X-rays may be useful to evaluate the device. Decisions about removing the device should be made on a case-by-case basis between health care providers and patient or caregiver. For patients who are identified as having a fractured absorber component, the surgeon should consider explantation surgery based on their independent clinical judgment. Firm is providing surgeons with a draft letter for their patients who have been implanted with affected Knee Systems from the Affected Lots. Firm recommends that surgeons customize the letter, send it to patients implanted with affected devices, and discuss with patients as appropriate. Share this Notice with all device users within your facility and network to ensure they are aware of this recall. This notification should also be shared with any organization if the care of patients with potentially affected devices has been transferred. Firm is prepared to assist patients with certain out-of-pocket costs related to this recall. Please correspond with the email address, care@moximed.com, or call us at 877-204-2922. Complete and return the response form via email to care@moximed.com
Quantity in Commerce115
DistributionUS Nationwide distribution in the states of CA, OR, NY, OH, TX, CO, NY, VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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