BEUDAMED
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    Terumo Ultrasonic air sensor, 3/8" by 3/32" (9.5 mm x 2.4 mm), Red, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5773, Terumo Cardiovascular Systems, Ann Arbor, MI 48103

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code KRL·September 19, 2007

    Terumo ultrasonic air sensor, 1/4" by 1/16" (6.4 mm x 1.6 mm), Black, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5785, Terumo Cardiovalvular Systems, Ann Arbor, MI 48103

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code KRL·September 19, 2007

    Air bubble detection cable assembly, catalog numbers 78-8067-7375-6 and 149892, Terumo Cardiovascular System, Ann Arbor, MI

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code KRL·October 15, 2010

    Terumo Ultrasonic air sensor, 1/4" by 3/32" (6.4 mm x 2.4 mm), Gold, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5791, Terumo Cardiovascular Systems, Ann Arbor, MI 48103

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code KRL·September 19, 2007

    Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM 189320 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM 189700 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 79 MM 189704 Vanguard Knee System, CR Mono Lock Tibial Bearing, 14 MM X 79 MM Product Usage: Knee prosthesis

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·June 3, 2020

    Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage:  Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.  Correction of varus, valgus, or posttraumatic deformity.  Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.  The device is a single use implant intended for implantation with bone cement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 26, 2016

    Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. Correction of varus, valgus, or posttraumatic deformity. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The device is a single use implant intended for implantation with bone cement.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code JWH·August 9, 2016

    Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nonsterile TASP CR L 3-9 CD TOP

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 27, 2014

    Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nonsterile TASP CR L 3-9 CD TOP

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·June 10, 2013

    Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM 189320 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM 189700 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 79 MM 189704 Vanguard Knee System, CR Mono Lock Tibial Bearing, 14 MM X 79 MM Product Usage: Knee prosthesis

    FDA Recall
    Terminated ·Biomet, Inc.·Product code JWH·April 17, 2020

    DrugCheck, Distributed by Express Diagnostics Int'l Inc., 1550 Industrial Drive, Blue Earth, MN 56013. Following cup Model numbers involved in the recall: 60670, 60700, 60713, 60717, 60870, 60923, 61012, 61019, 61023, 61024, 61040, 61042, 61057, 61102, 61105, 61203, 61204, 61206, 61208, 61301, 61303, 61401, 70603, 70809, 71032, 71043, 71055, 71065, 71202, 71204, 71205, 71401, 71402, 60718-3, 60720-6, 60925-A, 60927-3, 60930-A, 60980-3A, 61002-3, 61010-4, 61023-A, 61028-3A, 61039-4, 61040-A, 61055-A, 61056-3, 61057-6, 61100-3, 61102-3,61104-3,61105-5 CRL,61120-3,61202-4,61204-4,61204-A,61206-3A,61207-4,61302-3, 61303-A, 61401-A, 70660-3, 70716-3, 71045-A, 71055-6, 71102-3A, 71204-4, 71206-3A. In Vitro immunoassay screening device for the qualitative detection of multiple drugs of substances in human urine.

    FDA Recall
    Terminated ·Express Diagnostics Int'l., Inc.·Product code JXN·October 4, 2010

    Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10

    FDA Recall
    Terminated ·Karl Storz Endoscopy·Product code NKC·January 9, 2019

    Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope

    FDA Recall
    Terminated ·Karl Storz Endoscopy·Product code FET·June 20, 2016

    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.

    FDA Recall
    Terminated ·Karl Storz Endoscopy·Product code EQN·December 6, 2019

    Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit.

    FDA Recall
    Terminated ·Karl Storz Endoscopy·Product code LMD·June 25, 2014

    FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1

    FDA Recall
    Terminated ·Karl Storz Endoscopy·Product code GWG·February 20, 2019

    Flexible Intubation Fiberscope, Model # 11301AB1

    FDA Recall
    Terminated ·Karl Storz Endoscopy·Product code EOQ·April 24, 2019

    STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box), individually packaged in a sterile pouch (Catalog #20400161S), 10 pouches per cardboard box. Some of the pouches inside of cardboard box are incorrectly labeled as Catalog number 20400162S, High Flow Insufflation Tubing (with filter) For 26432020-1 THERMOFLATOR. The firm name on the label is Karl Storz Endoscopy-America, Inc., El Segundo, CA.

    FDA Recall
    Terminated ·Karl Storz Endoscopy·Product code NKC·October 10, 2017

    TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system. The system is a metal bone fixation device for stabilization and correction during the normal healing process. The purpose of the TL-HEX System is to provide a solution for deformity correction and keeping the bone segments aligned during the healing process. The device may only be applied by a physician, who is fully responsible for the surgical and post-operative procedures of the system and is able to manage possible mechanical and software limitations. Indications for use for adults and all pediatric subgroups except newborns include: post-traumatic joint contracture which has resulted in loss of range of motion, fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction, open and closed fracture fixation, pseudoarthrosis of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, correction of bony of soft tissue defects, joint arthrodesis, infected fractures or non unions.

    FDA Enforcement
    Class II ·Terminated·Orthofix Srl·June 13, 2018

    Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.

    FDA Enforcement
    Class II ·Terminated·Orthofix Srl·January 3, 2018