26 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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Ascension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.
FDA Recall
Terminated
·Integra Lifesciences Sales Llc·Product code KYJ·November 4, 2019
SWANSON FINGER JOINT #1, Part Number 4700001
FDA Recall
Terminated
·Wright Medical Technology, Inc.·Product code KYJ·November 8, 2016
SWANSON FINGER JOINT #2, Part Number 4700002
FDA Recall
Terminated
·Wright Medical Technology, Inc.·Product code KYJ·November 8, 2016
JariTrak Table Clamp, 1 inch diameter, vertical post, Catalog Number 206-160. The JariTrak Table Clamp with vertical post (206-160) is part of the Table Mounted Hardware that is used with the JariTrak Retractor System. The JariTrak self-retaining retractor system consists of the Table Clamp with Vertical Post, Flexible or Horizontal Bar with Universal Joint, Oval or Segment Rings, Tilting Blade Clamps and various blades. The product is supplied non-sterile and may be packaged individually or as part of the JariTrak retractor set.
FDA Recall
Terminated
·J. Jamner Surgical Instruments, Inc.·Product code KDC·November 14, 2006
ITW Dymon Medaphene Plus Orange Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt 16-oz. (1-lb.), 12 cans/case, containing 0.19% o-phenylphenol and 68.00% ethyl alcohol, Product 52920. The firm name on the label is ITW Dymon, Olathe, KS. The product is also distributed under the following private labels: (1) O.D.S. Orange Disinfectant Spray, Continental Research Corporation, St. Louis, MO; (2) Drummond American Bristol Orange Disinfectant Spray, Product DR8561, Sold by Drummond American Corporation, Vernon Hills, IL; (3) Romaine Medaphene Plus Disinfectant Spray Orange Fragrance, Manufactured For Romaine Companies, Tulsa, OK, Newburgh, IN, and Hopkinsville, KY; (4) State Discover Aerosol Disinfectant Citrus, Stock #109566 and #109567, Sold By State Industrial Products, Cleveland, OH; (5) Medisan Disinfectant Spray, Orange Scent, Distributed by Cape Janitor Supply, Cape Girardeau, MO; (6) DETCO Industries Germ Defense Disinfectant Spray, Orange Fragrance, Sold by DETCO Industries, Conway, AR; (7) Orange Disinfectant Spray, Manufactured for MASSCO, Inc., Norwood, MA; (8) Meyer Tri Power, Sold By Meyer Laboratory Inc., Blue Springs, MO; (9) Orange Surfacidal Disinfectant Spray, Packed for Check Mark, A Division of DM Resources, Inc., Irving, TX; (10) Citrus-Cidal Disinfectant Spray, Orange Fragrance, Sold By navy brand Manufacturing Company, St. Louis, MO; (11) Pro Chem Deocept Citra Disinfectant Spray, Orange Fragrance, Sold By Pro-Chem, Inc., Alpharetta, GA; (12) Ricmar Industries Tang-I-Cide Tangerine Fragrance Disinfectant, Sold Exclusively By Ricmar Industries, Inc., Elmhurst, IL; (13) Neutron NI-712 Disinfectant Spray, Stock #104787, A product of Neutron Industries, Phoenix, AZ.
FDA Recall
Terminated
·ITW Dymon·Product code LRJ·February 15, 2005
Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
FDA Recall
Terminated
·Cook Inc.·Product code MQF·December 19, 2017
KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant
FDA Enforcement
Class II
·Terminated·Mc-NEIL-PPC, Inc.·October 3, 2012
KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc.
FDA Enforcement
Class II
·Terminated·Mc-NEIL-PPC, Inc.·March 6, 2013
AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic.
FDA Recall
Terminated
·Sybron Dental Specialties·Product code DYJ·June 6, 2013
Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
FDA Recall
Terminated
·Brius Technologies Inc.·Product code DYJ·February 7, 2022
Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit.
FDA Recall
Terminated
·Caire, Inc.·Product code BYJ·October 23, 2007
Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
FDA Recall
Terminated
·Brius Technologies Inc.·Product code DYJ·February 7, 2022
CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit
FDA Recall
Terminated
·Caire, Inc.·Product code BYJ·October 10, 2022
CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit
FDA Recall
Terminated
·Caire, Inc.·Product code BYJ·October 10, 2022
AdvanSync is an orthodontic device intended for the orthodontic treatment of Class II malocclusions. The AdvanSync part numbers and lot numbers affected by this recall are as follows: Part Number: 600-4000 (Kits-include 10 Right 600-4000 and 10 Left Assemblies). Lot Numbers: 070990588, 070976869, 060971515, 060971514, 04094278D Part Number: 600-4040 (5-Pack, Left Assembly). Lot Numbers: 080901333, 080902356, 070981416, 060971299, 060976084 Part Number: 600-4041 (5-Pack, Right Assembly). Lot Numbers: 080902357, 080901335, 070981417, 060971304, 060976079
FDA Recall
Terminated
·Ormco Corporation·Product code DYJ·October 2, 2009
CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit
FDA Recall
Terminated
·Caire, Inc.·Product code BYJ·October 10, 2022
AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern.
FDA Recall
Terminated
·Allesee Orthodontic Appliances·Product code DYJ·February 24, 2014
Precision Medical- Easy Mate Portable Liquid Oxygen System (container), PM22010 Series, Model number 2201, Precision Medical, Inc., Northampton, PA 18067
FDA Recall
Terminated
·Precision Medical, Inc.·Product code BYJ·October 4, 2006
Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
FDA Recall
Terminated
·Brius Technologies Inc.·Product code DYJ·February 7, 2022
CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit
FDA Recall
Terminated
·Caire, Inc.·Product code BYJ·October 10, 2022