BEUDAMED
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    FDA Recall
    Open, Classified ·Ontact Inc 10944 Playa Del Sol·Product code MVN·March 20, 2024

    Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty. The S2 Mini Drill System consists of a foot pedal and a drill, with an integrated micromotor, to drive various burs.

    FDA Recall
    Open, Classified ·Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland·Product code ERL·September 11, 2020

    Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spine and cranium.

    FDA Recall
    Open, Classified ·Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland·Product code ERL·September 11, 2020

    Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.

    FDA Recall
    Open, Classified ·Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland·Product code ERL·September 11, 2020

    Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.

    FDA Recall
    Open, Classified ·Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland·Product code ERL·September 11, 2020

    Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.

    FDA Recall
    Open, Classified ·Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland·Product code ERL·September 11, 2020

    REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R

    FDA Recall
    Open, Classified ·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code MBF·May 30, 2023

    PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610

    FDA Recall
    Open, Classified ·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code JWH·October 27, 2023

    PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile

    FDA Recall
    Open, Classified ·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code PHX·May 19, 2025

    Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE 0459, EN Navigation Kit. Compatible with linear instruments of diameter ranging from 0.5 mm to 3.0 mm (25G to 11G), Sterile, Rx Only,

    FDA Recall
    Open, Classified ·Imactis 20 Rue Du Tour De L Eau St Martin D Heres France·Product code JAK·August 1, 2019

    PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM REGULAR/1975.14.800, BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510, BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810, BASEPLATE D.25MM FULL WEDGED 15-degrees/1975.14.615, BASEPLATE D.28MM FULL WEDGED 15-degrees/1975.14.815, BASEPLATE D.28MM FULL WEDGED 15-degrees X/1975.14.865, BASEPLATE D.25 MM FULL WEDGED 20-degrees/1975.14.620, BASEPLATE D.28 MM FULL WEDGED 20-degrees/1975.14.820, BASEPLATE D.28 MM FULL WEDGED 20-degrees X/1975.14.870

    FDA Recall
    Open, Classified ·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code MBF·August 29, 2023

    REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R

    FDA Recall
    Open, Classified ·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code MBF·May 30, 2023

    Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)

    FDA Recall
    Open, Classified ·Imactis 20 Rue Du Tour De L Eau St Martin D Heres France·Product code JAK·August 24, 2020

    TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.

    FDA Recall
    Open, Classified ·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code JDB·October 2, 2024

    TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)

    FDA Recall
    Open, Classified ·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code JDC·January 25, 2023

    SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210

    FDA Recall
    Open, Classified ·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code MBF·February 21, 2023

    PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile

    FDA Recall
    Open, Classified ·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code PHX·May 19, 2025