BEUDAMED
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    smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

    FDA Recall
    Open, Classified ·Smith & Nephew Inc·Product code JWH·October 2, 2024

    smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

    FDA Recall
    Open, Classified ·Smith & Nephew Inc·Product code JWH·October 2, 2024

    VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only

    FDA Recall
    Open, Classified ·bioMerieux, Inc.·Product code LON·June 26, 2025

    The Cholestech LDX System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or venipuncture. The sample is applied to an Cholestech LDX cassette. Description/Part: Cholestech LDX Lipid Profile GLU Cassette/10-991, 99021, 14-531; Cholestech LDX TC HDL GLU Cassette/10-990; Cholestech LDX Lipid Profile Cassette/10-989; Cholestech LDX TC HDL Cassette/10-987

    FDA Recall
    Open, Classified ·Alere San Diego, Inc.·Product code CGA·June 24, 2022

    Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170

    FDA Recall
    Open, Classified ·Alere San Diego, Inc.·Product code CGA·March 1, 2024

    VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266

    FDA Recall
    Open, Classified ·Ortho Clinical Diagnostics Inc·Product code CGN·July 12, 2018

    Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 11206252

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023

    directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2

    FDA Recall
    Open, Classified ·Accriva Diagnostics, Inc.·Product code GGN·April 30, 2026

    Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023

    Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023

    VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code CGN·July 3, 2024

    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

    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

    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