BEUDAMED
    903 results · 23ms · Sources: EU EUDAMED, US FDA

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    UNKNOWN STEM FLEX SIZE 3

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·September 26, 2024

    The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr, b) Catalog # DWH041 - Diameter 41 m m Height 15 mm Eccentric LOW (1.5) Material PyC/CoCr, c) Catalog # DWH043 - Diameter 43 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr, d) Catalog # DWH046 - Diameter 46 mm Height 17 mm Eccentric LOW (1.5) Material PyC/CoCr, e) Catalog # DWH048 - Diameter 48 mm Height 18 mm Eccentric LOW (1.5) Material PyC/CoCr, f) Catalog # DWH050 - Diameter 50 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr, g) Catalog # DWH051 - Diameter 50 mm Height 19 mm Eccentric LOW (1.5) Material PyC/CoCr, h) Catalog # DWH052 - Diameter 52 mm Height 19 mm Eccentric LOW (1.5) Material PyC/CoCr, i) Catalog # - DWH053 - Diameter 52 mm Height 23 mm Eccentric LOW (1.5) Material PyC/CoCr, j) Catalog # DWH054 - Diameter 54 mm Height 23 mm Eccentric LOW (1.5) Material PyC/CoCr, k) Catalog # DWH139 - Diameter 39 mm Height 14 mm Eccentric HIGH (3.5) Material PyC/CoCr, l) Catalog # DWH141 - Diameter 41 mm Height 15 mm Eccentric HIGH (3.5) Material PyC/CoCr, m) Catalog # DWH143 - Diameter 43 mm Height 16 mm Eccentric HIGH (3.5) Material PyC/CoCr, n) Catalog # DWH146 - 46 mm Height 17 mm Eccentric HIGH (4) Material PyC/CoCr, o) Catalog # DWH148, - Diameter 48 mm Height 18 mm Eccentric HIGH (4) Material PyC/CoCr, p) Catalog # DWH150 - Diameter 50 mm Height 16 mm Eccentric HIGH (4) Material PyC/CoCr, q) Catalog # DWH151 - Diameter 50 mm Height 19 mm Eccentric HIGH (4) Material PyC/CoCr, r) Catalog # DWH152 - Diameter 52 mm Height 19 mm Eccentric HIGH (4) Material PyC/CoCr, s) Catalog # DWH153 - Diameter 52 mm Height 23 mm Eccentric HIGH (4) Material PyC/CoCr, t) Catalog # DWH154 - Diameter 54 mm Height 23 mm Eccentric HIGH (4) Material PyC/CoCr,

    FDA Recall
    Open, Classified ·Tornier S.A.S. 161 Rue Lavoisier Montbonnot St Martin France·Product code QHE·June 25, 2021

    The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr, b) Catalog # DWH041 - Diameter 41 m m Height 15 mm Eccentric LOW (1.5) Material PyC/CoCr, c) Catalog # DWH043 - Diameter 43 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr, d) Catalog # DWH046 - Diameter 46 mm Height 17 mm Eccentric LOW (1.5) Material PyC/CoCr, e) Catalog # DWH048 - Diameter 48 mm Height 18 mm Eccentric LOW (1.5) Material PyC/CoCr, f) Catalog # DWH050 - Diameter 50 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr, g) Catalog # DWH051 - Diameter 50 mm Height 19 mm Eccentric LOW (1.5) Material PyC/CoCr, h) Catalog # DWH052 - Diameter 52 mm Height 19 mm Eccentric LOW (1.5) Material PyC/CoCr, i) Catalog # - DWH053 - Diameter 52 mm Height 23 mm Eccentric LOW (1.5) Material PyC/CoCr, j) Catalog # DWH054 - Diameter 54 mm Height 23 mm Eccentric LOW (1.5) Material PyC/CoCr, k) Catalog # DWH139 - Diameter 39 mm Height 14 mm Eccentric HIGH (3.5) Material PyC/CoCr, l) Catalog # DWH141 - Diameter 41 mm Height 15 mm Eccentric HIGH (3.5) Material PyC/CoCr, m) Catalog # DWH143 - Diameter 43 mm Height 16 mm Eccentric HIGH (3.5) Material PyC/CoCr, n) Catalog # DWH146 - 46 mm Height 17 mm Eccentric HIGH (4) Material PyC/CoCr, o) Catalog # DWH148, - Diameter 48 mm Height 18 mm Eccentric HIGH (4) Material PyC/CoCr, p) Catalog # DWH150 - Diameter 50 mm Height 16 mm Eccentric HIGH (4) Material PyC/CoCr, q) Catalog # DWH151 - Diameter 50 mm Height 19 mm Eccentric HIGH (4) Material PyC/CoCr, r) Catalog # DWH152 - Diameter 52 mm Height 19 mm Eccentric HIGH (4) Material PyC/CoCr, s) Catalog # DWH153 - Diameter 52 mm Height 23 mm Eccentric HIGH (4) Material PyC/CoCr, t) Catalog # DWH154 - Diameter 54 mm Height 23 mm Eccentric HIGH (4) Material PyC/CoCr,

    FDA Enforcement
    Class II ·Ongoing·Tornier S.A.S.·August 25, 2021

    UNKNOWN PYC HUMERAL HEAD

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code QKW·November 11, 2024

    UNKNOWN PYROCARBON IMPLANT

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code QKW·October 8, 2024

    TORNIER PYROCARBON HUM HEAD DIA 50MMX16MMX1.5MM ECC

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code QKW·June 13, 2025

    AEQUALIS ASCEND FLEX HUMERAL STEM

    FDA Adverse Event
    Injury ·Product code KWS·April 8, 2020

    EPS ORTHOLOC LATERAL LEFT PLATE

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY INC·Product code HRS·February 17, 2026

    PARACENTESIS PROCEDURE TRAY

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC·Product code PYC·March 12, 2026

    SAFETY CENTESIS CATHETER TRAY 8R

    FDA Adverse Event
    Injury ·CARDINAL HEALTH 200, LLC.·Product code PYC·March 7, 2025

    TORNIER HRS LOCKING CAP

    FDA Adverse Event
    Injury ·TORNIER INC·Product code HSD·May 7, 2026

    TORNIER HRS ASSEMBLY SCREW 50MM

    FDA Adverse Event
    Injury ·TORNIER INC·Product code HSD·May 7, 2026

    TORNIER HRS PTC DISTAL STEM DIA 15

    FDA Adverse Event
    Injury ·TORNIER INC·Product code HSD·May 7, 2026

    TORNIER PYROCARBON HUM HEAD DIA 52MMX19MMX1.5MM ECC LO

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·April 30, 2025

    UNKNOWN ASCEND FLEX STEM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·November 11, 2024

    Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282

    FDA Recall
    Terminated ·Cook Inc.·Product code PYC·April 9, 2019

    Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030

    FDA Recall
    Terminated ·Cook Inc.·Product code PYC·April 9, 2019

    PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code PYC·April 21, 2026

    Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284

    FDA Recall
    Terminated ·Cook Inc.·Product code PYC·April 9, 2019

    Thoracentesis Set, RPN C-THS-850, Order # G03286

    FDA Recall
    Terminated ·Cook Inc.·Product code PYC·April 9, 2019