228 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. GoDirect Implants Part Number: 423011, 423013, 424708, 424710, 424713,433010,433710
FDA Recall
Terminated
·Implant Direct Sybron Manufacturing, LLC·Product code DZE·March 4, 2016
Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code DZE·March 14, 2019
GM Helix Acqua Implant 3.5x10, Article No. 140.944
FDA Recall
Terminated
·Jjgc Industria E Comercio De Materials Dentarios Sa Av Juscelino Kubitschek De Oliveira Curitiba Brazil·Product code DZE·October 11, 2021
FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code DZE·July 18, 2016
Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
FDA Recall
Terminated
·Keystone Dental Inc·Product code DZE·March 9, 2017
Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
FDA Recall
Terminated
·Implant Direct Sybron Manufacturing LLC·Product code DZE·October 7, 2019
Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
FDA Recall
Terminated
·Implant Direct Sybron Manufacturing LLC·Product code DZE·October 11, 2019
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
FDA Recall
Terminated
·Straumann USA LLC·Product code DZE·November 30, 2021