19 results
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28ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve. Model: D803FGA. Private labeled for P.J. Dahlhausen in Germany. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code KZD·September 20, 2008
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
Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
FDA Recall
Open, Classified
·Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JDI·July 22, 2022
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
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
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
Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code HYJ·December 19, 2017
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
Cardinal Health Custom Sterile Latex Free Convenience Kits; sterile single use disposable devices packaged in plastic pouches; Cardinal Health, McGaw Park, IL 60085 U.S.A.; identified by the following catalog numbers: a) Cat. POOCOTFGB - Sterile Ortho Pack b) Cat.SOP22ARCLC - Sterile Arthoscopy Pack c) Cat. SOP30ARCOB - Sterile Knee Arthroscopy Pack d) Cat. SOP30ARCOC - Sterile Knee Arthroscopy Pack e) Cat. SOP30ARKGC - Sterile Arthroscopy Pk f) Cat. SOP30ARMCB - Sterile McCallum Surgical Pack g) Cat. SOP30ARNOA - Sterile Arthroscopy Pack h) Cat. SOP30KANRA - Sterile Knee Arthroscopy Pack i) Cat. SOP30LENHC - Strl Major Lower Extremity Pk j) Cat. SOP30SADTE - Strl Shoulder Arthroscopy Pack k) Cat. SOP30THDTD - Sterile Total Hip Pack l) Cat. SOP30THNOA - Sterile Total Hip Pk m) Cat. SOP30THSJA - Sterile Total Hip Pack n) Cat. SOP30TKSJA - Sterile Total Knee Pack o) Cat. SOP30THVCH - Sterile Total Hip Pack p) Cat. SOP30TKVCE - Sterile Total Knee Pack
FDA Recall
Terminated
·Cardinal Health·Product code LRO·October 3, 2005