54 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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TENET Medical Engineering Wrist Stabilization Kit, Medium; REF (Part) #7692; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.
FDA Recall
Terminated
·Tenet Medical Engineering Inc
11979 40th St Se /#203 Ab
Calgary Canada·Product code JEB·November 23, 2007
The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. Product Usage: The cylinders are used to lock the surgical table in place.
FDA Recall
Terminated
·Schaerer Medical USA Inc·Product code JEB·September 27, 2016
TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) #7691; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.
FDA Recall
Terminated
·Tenet Medical Engineering Inc
11979 40th St Se /#203 Ab
Calgary Canada·Product code JEB·November 23, 2007
Smith & Nephew Hip Positioning System Ref: 72200624 with System Components: Perineal Post 72200631 Universal Hip Distractor 72200626 Knee Holder 72200627 Well Leg Holder 72200632 Supine Table Extension 72200629
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code JEB·May 22, 2006
The 2nd Assist Knee Positioner
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code JEB·September 7, 2017
TENET Medical Engineering Wrist Stabilization Kit, Large; REF (Part) #7693; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.
FDA Recall
Terminated
·Tenet Medical Engineering Inc
11979 40th St Se /#203 Ab
Calgary Canada·Product code JEB·November 23, 2007
TruSystem Surgical Table (TS7000) Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000, in conjunction with operating table components is intended for the use of patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. The Leg Section One Part Light HU is attached to coupling point L on the operating table and is used to position the patients legs during pre-op and post-op surgery.
FDA Recall
Terminated
·Trumpf Medical Systems, Inc.·Product code JEB·October 28, 2013
Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
FDA Recall
Terminated
·Allen Medical Systems·Product code JEB·October 6, 2017
Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118. Product Usage: The cylinders are used to lock the surgical table in place.
FDA Recall
Terminated
·Schaerer Medical USA Inc·Product code JEB·September 27, 2016
Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base Plate and Foot Piece: Alvarado Foot Piece: Item Number: 00-1320-010-00 Alvarado Knee Holder Base Plate Assembly: Item Number: 00-1320-011-00 Alvarado II Foot Piece: Item Number: 00-1320-210-00 Alvarado II Base Plate: Item Number: 00-1320-211-00 Product Usage: This device is designed to hold the patient s knee in the selected position during surgery. The Alvarado Knee Holder includes a Base Plate assembly with two rows of slotted hooks. These rows extend upward from the base plate for a sufficient length to provide adequate selective adjustment. A Foot Piece is mounted on an alignment rod that is pivotally engaged into the hook portion of the slots.
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code JEB·April 16, 2019
Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
FDA Recall
Terminated
·Allen Medical Systems·Product code JEB·October 6, 2017
Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT) High Pressure Check Valve, Catalog number AVA 500 MPAT, Material number 3018231.
FDA Recall
Terminated
·Medrad Inc·Product code DXT·January 6, 2010
Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code JAK·October 14, 2011
Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS·October 14, 2011
ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 6 degrees lordosis, 12 mm height
FDA Enforcement
Class II
·Terminated·4-Web Inc.·December 24, 2014
Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
FDA Recall
Terminated
·Arrow International Inc·Product code DQY·October 17, 2017
Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
FDA Recall
Terminated
·Arrow International Inc·Product code DQY·October 17, 2017
Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018
FDA Recall
Terminated
·Arrow International Inc·Product code DQY·October 17, 2017
ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2018
FDA Recall
Terminated
·Arrow International Inc·Product code FOZ·October 17, 2017
AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018
FDA Recall
Terminated
·Arrow International Inc·Product code FOZ·October 17, 2017