BEUDAMED
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    GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code LXH·April 13, 2022

    GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery

    FDA Recall
    Terminated ·Medacta Usa·Product code KRO·April 17, 2015

    Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consists of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code NDP·November 15, 2017

    Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4901/A IN4902/A IN4903/A IN4904/A IN4905/A IN4906/A IN4907/A IN4908 IN4909 IN4910 IN4911/A IN4912 IN4913/A IN4914/A IN4915 IN4916/A IN4917/A IN4918/A IN4919/A

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code PTM·December 4, 2025

    GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.

    FDA Recall
    Terminated ·Medacta Usa·Product code HSB·September 22, 2014

    Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consist of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code LXH·June 26, 2017

    Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code KRO·May 19, 2017

    The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code JWH·October 24, 2017

    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)

    FDA Recall
    Terminated ·GSK Consumer Healthcare·Product code N/A·April 25, 2016

    ClubMax Laser Projection Series

    FDA Recall
    Open, Classified ·Gk Photonics Inc·Product code REA·July 10, 2019

    Logolas Laser Projection Series

    FDA Recall
    Open, Classified ·Gk Photonics Inc·Product code REA·July 10, 2019

    Burstberry Laser Projection Series

    FDA Recall
    Open, Classified ·Gk Photonics Inc·Product code REA·July 10, 2019

    Atom Laser Projection Series

    FDA Recall
    Open, Classified ·Gk Photonics Inc·Product code REA·July 10, 2019

    Spectrum Laser Projection Series

    FDA Recall
    Open, Classified ·Gk Photonics Inc·Product code BRX·July 10, 2019

    Maxim Laser Projection Series

    FDA Recall
    Open, Classified ·Gk Photonics Inc·Product code REA·July 10, 2019

    AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-12F-45/80. Product is labeled as Sterile EO. The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code GBK·November 23, 2004

    AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-9F-180/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code GBK·November 23, 2004

    AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-6F-180/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code GBK·November 23, 2004

    AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-9F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code GBK·November 23, 2004

    AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-12F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code GBK·November 23, 2004