11 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Completed
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Orthopedic Split Drape Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
FDA Enforcement
Class II
·Completed·Aesculap Implant Systems LLC·July 27, 2022
WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures
FDA Enforcement
Class II
·Completed·Teleflex Medical·May 24, 2017
Orthopedic Split Drape Pack - contains Devon Light Glove Used during surgery
FDA Recall
Completed
·Stradis Healthcare, LLC.·Product code LRO·April 20, 2015
TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
FDA Recall
Completed
·Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JDI·July 12, 2022
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
FDA Recall
Completed
·Aesculap Implant Systems LLC·Product code LXH·November 12, 2019
Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tray Trial, Cat. #321-00-11; (4) HAT LAT Right Tray Trial, Cat. #321-00-12; (5) HAT EXT LAT Left Trial, Cat. #321-00-21; and (6) HAT EXT LAT Right Trial, Cat. #321-00-22. The Humeral Augmented Tray is designed to function with the Equinoxe Reverse Shoulder System orthopedic implant components.
FDA Enforcement
Class II
·Completed·Exactech, Inc.·July 7, 2021
WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures
FDA Recall
Completed
·Teleflex Medical·Product code GDT·March 24, 2017
Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tray Trial, Cat. #321-00-11; (4) HAT LAT Right Tray Trial, Cat. #321-00-12; (5) HAT EXT LAT Left Trial, Cat. #321-00-21; and (6) HAT EXT LAT Right Trial, Cat. #321-00-22. The Humeral Augmented Tray is designed to function with the Equinoxe Reverse Shoulder System orthopedic implant components.
FDA Recall
Completed
·Exactech, Inc.·Product code PHX·May 11, 2021
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
FDA Enforcement
Class II
·Completed·SAFE ORTHOPAEDICS LLC·August 31, 2022
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
FDA Recall
Completed
·SAFE ORTHOPAEDICS LLC·Product code NKB·June 3, 2022