91 results
·
11ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Gender Solutions" Patello-Femoral Component
FDA Recall
Terminated
·Zimmer, Inc.·Product code KRR·August 30, 2013
Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). History of patellar dislocation or patella fracture. Dysplasia-induced degeneration. This device is intended for cemented use only."
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code KRR·January 11, 2016
ZIMMER PATELLA FEMORAL JOINT Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code KRR·November 29, 2017
Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.
FDA Recall
Terminated
·Zimmer, Inc.·Product code KRR·July 30, 2014
All instrumentation associated with the Prelude PF Resurfacing Knee System.
FDA Recall
Terminated
·Biomet, Inc.·Product code KRR·March 9, 2016
PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code KRR·November 29, 2017
The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials.
FDA Enforcement
Class II
·Terminated·Kerr Corporation·November 14, 2012
Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. Freedom Cordless LED Light System is a Class I Medical Device. The device listing number this product is E115952. The intended use of this device is to illuminate oral structures and operating areas.
FDA Enforcement
Class II
·Terminated·Kerr Corporation·November 28, 2012
The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. Laser Loupes are available with four (4) different filters of different colors. Each colored filter is associated with specific laser frequency ranges. The device listing number for this product is E160359. The intended use of this device is to magnify the operatory field and provide laser eye protection.
FDA Enforcement
Class II
·Terminated·Kerr Corporation·November 28, 2012
BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant is a synthetic, multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery, ridge preservation, ridge augmentation, augmentations in the maxillary sinus, repair of periodontal defects and bone voids associated with dental implant placement.
FDA Enforcement
Class II
·Terminated·Kerr Corporation·November 28, 2012
Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this device is to be used as a dental restorative material in the treatment of dental caries.
FDA Enforcement
Class II
·Terminated·Kerr Corporation·June 25, 2014
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
FDA Enforcement
Class II
·Terminated·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·June 12, 2019
Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations.
FDA Enforcement
Class II
·Terminated·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·April 17, 2013
NX3 Try-In Gel. The product is used as a tooth shade resin material.
FDA Enforcement
Class II
·Terminated·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·September 25, 2013
Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is to be used for the cementation of indirect restorations including veneers, inlays, onlays, bridges, posts, and the cementation of crown restorations to implant abutments.
FDA Enforcement
Class II
·Terminated·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·May 6, 2020
Tooth bonding resin. Optibond Solo Plus Bottle Kit, Part Number 31514, Lot Number 429106
FDA Recall
Terminated
·Kerr Corp·Product code KLE·March 3, 2006
PREMISE, PART NO. 34086, 10 PACK UNIDOSE PREMISE A2 SAMPLE, dental composite
FDA Recall
Terminated
·Kerr Corp·Product code EBF·September 5, 2008
PREMISE, PART NO. 32674, 10 PACK UNIDOSE PREMISE C2 OPAQUE, dental composite
FDA Recall
Terminated
·Kerr Corp·Product code EBF·September 5, 2008
PREMISE, PART NO. 32812, 10 PACK UNIDOSE PREMISA A2 (INTERNATIONAL ONLY), dental composite
FDA Recall
Terminated
·Kerr Corp·Product code EBF·September 5, 2008
PREMISE, PART NO. 32677, 10 PACK UNIDOSE PREMISE TRANS GREY, dental composite
FDA Recall
Terminated
·Kerr Corp·Product code EBF·September 5, 2008