33 results
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30ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medium, W: 65mm 16-2817/37 Tibial Component Modular, Large, W: 75mm
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·May 22, 2024
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
FDA Recall
Open, Classified
·Roche Diagnostics Operations, Inc.·Product code JJE·December 8, 2020
Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001
FDA Recall
Open, Classified
·Roche Diagnostics Operations, Inc.·Product code JJE·December 8, 2020
Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11, 15-2835/12, 15-2836/11, 15-2836/12, 15-2837/11, 15-2837/12, 15-2838/11, 15-2838/12, 15-3815/11, 15-3815/12, 15-3816/11, 15-3816/12, 15-3817/11, 15-3817/12, 15-3818/11, 15-3818/12, 15-8521/05, 15-8521/07, 15-8521/09, 15-8521/11, 15-8521/15, 15-8521/25, 15-8521/27, 15-8521/29, 15-8521/31, 15-8521/33
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·May 22, 2024
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
FDA Recall
Open, Classified
·Medtronic Sofamor Danek USA Inc·Product code LXH·November 19, 2021
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code KRO·November 10, 2025
OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602
FDA Recall
Open, Classified
·Biomet, Inc.·Product code HSB·November 29, 2022
CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
FDA Recall
Open, Classified
·CardioQuip, LLC·Product code DWC·October 24, 2023
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
FDA Recall
Open, Classified
·CardioQuip, LLC·Product code DWC·October 24, 2023
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
FDA Recall
Open, Classified
·Exactech, Inc.·Product code HWA·February 3, 2026
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
Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·February 14, 2025
Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·February 14, 2025
CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
FDA Recall
Open, Classified
·CardioQuip, LLC·Product code DWC·October 19, 2023
Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·February 14, 2025
CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
FDA Recall
Open, Classified
·CardioQuip, LLC·Product code DWC·October 19, 2023
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code CEO·September 3, 2025
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code FRN·August 15, 2024
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code FRN·August 15, 2024
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code FRN·August 15, 2024