18 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
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
Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.
FDA Recall
Terminated
·Exactech, Inc.·Product code JWH·September 19, 2017
Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·May 27, 2015
Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·November 29, 2017
Presource Custom Sterile Packs containing the Cardiovascular Split Drape II; the custom sterile packs were packaged with the bulk, non-sterile drapes and then the complete custom pack was sterilized; packaged by Cardinal Health Medical Products and Services, McGaw Park, IL 60085; identified by the following catalog numbers: a) SVC13AMEMK - Sterile Open Heart Adult Pk; b) SCV31OHMPJ - Sterile Open Heart w Drapes Pk; c) SVC42OPVCG - Sterile Open Heart Adult Pack; d) SCV32CPMUO - Sterile CAB 146060 Pack; e) SCV34OHTMJ - Sterile Basin Pack; f) SCV31LVLUM - Sterile Liver Transplant Pack; g) SCV19CVHHF - Sterile Cardiovascular Pack; h) SCV11ADLLD - Sterile Open Heart/Adult; i) SCV92CBHRB - Sterile CABG Pack; j) SCV92CASIA - Sterile Cardiovascular Pack; k) SBA32GSMUL - Sterile General Surgery Pack; l) SCV30OHKWA - Strl **** Open Heart Pack; m) SBA31LVLUM - Sterile Liver Transplant Pack; n) SBA35LTBLQ - Sterile Lung Transplant Pack; o) SCV44CVDEB - Sterile CV Pack; p) SCV22OHMES - Open Heart Pack; q) SCV23AOSFH - Open Heart Part 3; r) SCV43OHHRF - Open Heart; s) SCV24CAGME - CABG Drape Pack; t) SAN12CCKGB - Cardiac Pack; u) SBA13BRBSE - Breast Reduction; v) SCV11CBNYP - CABG G 3; w) SCV11CESLB - C.V. Drape Pack; x) SCV11CGCPR - CABG; y) SCV11CGXXB - CABG Pack; z) SCV11CJICL - Cardiac Major; aa) SCV11CTMUK - C T Set Up; bb) SCV11DPMYG - **** S Drape Pack; cc) SCV11HEMMI - Open Heart A B; dd) SCV11MRCPE - Major Cardiac; ee) SCV11OCNYN - OH CABG; ff) SCV11OHLD2 - Open Heart A&B Pack; gg) SCV11OHNMC - Open Heart; hh) SCV11OPLKC - O P CABG; ii) SCV11VASLB - C V Valve Drape; jj) SCV11VLNYM - G 3 Valve; kk) SCV12OHYHY - Graft and Linen; ll) SCV13AABSV - Aortic Aneurysm; mm) SCV13AMEMJ - Open Heart Pack B; nn) SCV13BBEMC - Cardio-Thoracic Aux; oo) SCV13CB767 - CABG; pp) SCV13OHCAI - Open Heart Pk; qq) SCV13OOBIG - Open Heart Drape; rr) SCV14O1BGO - Open Heart Pack A; ss) SCV22OHPGA - Open Heart Pack; tt) SCV22OOMSE - Open Heart Preferred; uu) SCV24OH20A - Open Heart Drape Pack; vv) SCV43DREJI - Open Heart Drape Pack; ww) SCV69OH17E - Open Heart; xx) SCV59HVSGJ - Heart Valve Pack; yy) SCV59OHNVM - Open Heart Pack; zz) SCV53HTDMG - ***** Open Heart; aaa) SCV56CH11A - Open Heart Pack; bbb) SCV59MJTCW - Open Heart Pack; ccc) SCV52OH97F - Open Heart Pack; ddd) SCV41OHHIE - Open Heart Pack; eee) SCV52HTSJE - Open Heart Pack; fff) SCV59OHMHV - Basic Heart Pack; ggg) SCV11MJTJI - Open Heart
FDA Recall
Terminated
·Cardinal Health·Product code LRO·September 27, 2006