35 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Ami HTX.
FDA Recall
Open, Classified
·Spectral Instruments Inc·Product code RCE·May 13, 2025
Lago X
FDA Recall
Open, Classified
·Spectral Instruments Inc·Product code RCE·May 13, 2025
HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Screws for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code JEY·July 11, 2008
BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK. BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, WWW.BIOMETMICROFIXATION.COM. Intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code DZL·March 17, 2010
EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01
FDA Recall
Terminated
·Exactech, Inc.·Product code HTX·May 25, 2017
EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42, and Catalog #: 321-05-46
FDA Recall
Terminated
·Exactech, Inc.·Product code HTX·May 25, 2017
EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01
FDA Recall
Terminated
·Exactech, Inc.·Product code HTX·May 25, 2017
EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01
FDA Recall
Terminated
·Exactech, Inc.·Product code HTX·May 25, 2017
EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #: 321-25-42 and Catalog #: 321-25-46
FDA Recall
Terminated
·Exactech, Inc.·Product code HTX·May 25, 2017
EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38, Catalog #: 321-45-42 and Catalog #: 321-45-46
FDA Recall
Terminated
·Exactech, Inc.·Product code HTX·May 25, 2017
ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A; orthopedic surgery
FDA Recall
Open, Classified
·Sklar Instruments·Product code HTX·December 3, 2024
TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.
FDA Recall
Open, Classified
·Trackx Technology Inc·Product code OWB·October 24, 2022
Tachos ATx
FDA Recall
Terminated
·Biotronik Inc·Product code LWS·April 29, 2004
ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: TX Stapler, Reloadable, Linear 30 mm and 60 mm, item numbers TX30 and TX60
FDA Recall
Terminated
·International Surgical Supply, Inc.·Product code KDC·September 3, 2003
Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX Snap has a unique set of 2 or more reflective markers. By having unique configurations of reflective markers, it is possible to identify which TrackX Snap is in the field of view of the camera(s). As such, it is also possible to have multiple TrackX Snaps in the field at once and to have different TrackX Snaps for different surgical instruments. The device is considered to be a sterile accessory.
FDA Recall
Open, Classified
·Trackx Technology Inc·Product code OWB·September 3, 2024
ReSolve Halo - Open Back Halo Ring, Model Number: 505300D The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.
FDA Recall
Terminated
·Ossur Engineering, Inc·Product code HAX·November 9, 2008
ReSolve Halo - Open Back Halo Ring, Model Number: 510400D The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.
FDA Recall
Terminated
·Ossur Engineering, Inc·Product code HAX·November 9, 2008
Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss Instruments brand names.
FDA Recall
Terminated
·Instrumed International, Inc.·Product code HAX·September 8, 2014
Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Millennium Surgical, Boss Instruments, and Stealth Surgical brand names
FDA Recall
Terminated
·Instrumed International, Inc.·Product code HAX·September 8, 2014
Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML/MED; JT-400/ J TONG COMPONENT TRAY
FDA Recall
Terminated
·Ossur Americas·Product code HAX·June 21, 2018