BEUDAMED
    7 results · 39ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty.

    FDA Recall
    Terminated ·Materialise N.V. 15 Technologielaan Heverlee Belgium·Product code JWH·February 4, 2015

    TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001

    FDA Recall
    Terminated ·Materialise N.V. Technologielaan 15 Heverlee Belgium·Product code JEY·February 3, 2020

    Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-image scans.

    FDA Recall
    Terminated ·Materialise N.V. Technologielaan 15 Heverlee Belgium·Product code KWS·July 17, 2020

    Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.

    FDA Recall
    Terminated ·Materialise N.V. 15 Technologielaan Heverlee Belgium·Product code OSF·September 23, 2015

    MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01

    FDA Recall
    Completed ·Materialise N.V. Technologielaan 15 Heverlee Belgium·Product code JWH·April 26, 2023

    ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101

    FDA Recall
    Completed ·Materialise N.V. Technologielaan 15 Heverlee Belgium·Product code JEY·June 19, 2023

    TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013

    FDA Recall
    Terminated ·Materialise N.V. Technologielaan 15 Heverlee Belgium·Product code JEY·February 3, 2020