46 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
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
Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 6, 2013
1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·February 26, 2020
STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·October 16, 2019
Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.
FDA Enforcement
Class II
·Terminated·Ceterix Orthopedics, Inc.·September 5, 2018
NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.
FDA Enforcement
Class II
·Terminated·Ceterix Orthopedics, Inc.·November 18, 2015
Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 27, 2016
Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 27, 2016
Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 27, 2016
Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 27, 2016
Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·October 25, 2017