Events

Rappel de PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is comprised of an oxidized regenerated cellulose (ORC) fabric, and PROLENE Soft Mesh, a nonabsorbable polypropylene mesh, which is encapsulated by a polydioxanone polymer. The polypropylene mesh side of the product allows for tissue ingrowth while the ORC side provides a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue and organ surfaces during the wound-healing period to minimize tissue attachment to the mesh. The polydioxanone provides a bond to the ORC layer.

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Ethicon, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    34279
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0449-06
  • Date de mise en oeuvre de l'événement
    2006-01-04
  • Date de publication de l'événement
    2006-01-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-09-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43417
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Mesh, Surgical, Polymeric - Product Code FTL
  • Cause
    Lots of proceed surgical mesh may delaminate from the polypropylene mesh during certain hernia repairs. exposure of the polypropylene layer to the bowel prior to reperitonealization could increase the risk of adhesions and bowel fistulization.
  • Action
    The recall was initiated on 12/21/2005. The recall to the customers were initiate via letter with return receipt on 1/4/2006.

Device

PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh designed for the repair of herni...
  • Modèle / numéro de série
    Product Code -- Lot: PCDD1---- UHG068; UJG096; UJG110; UJG131; UJG149; UKG264; ULG335; ULG316; ULG313; ULG342; ULG374; ULG385; ULG409; UMG490; UMG492; UMG004; UHG038; UHG025; UHG021;   PCDM1 ---- UJG078; UJG082; UJG085; UJG087; UJG109; ULG103; ULG101; ULG095; ULG125; UJG128; ULG139; UJG142; UKG184; UKG183; UKG181; UKG175; UKG161; UKG187; UKG203; UKG201; UEG883; UKG231; UKG239; UKG241; UKG279; UKG253;  UKG250; UKG243; UKG267; UKG266; UKG256; ULG309; ULG287; ULG328; ULG311; ULG370; ULG369; ULG340; ULG337; ULG393; ULG399; ULG400; ULG373; ULG401; ULG405; UMG424; UMG425; UMG426; UMG448; UMG449; UMG479; UMG478; UMG477; UMG473; UMG450; UMG504; UMG486; UGG001; UGG999; UHG014; UHG040; UHG031; UHG026;   PCDN1 ----- UHG056; UHG059; UHG072; UHG054; UJG075; UJG077; UJG088; UJG092; UJG099; UJG107; UJG134; UJG129; UJG122; UJG144; UJG154; UJG156; UJG160; UKG176; UKG170; UKG169; UKG166; UKG177; UKG190; UKG198; UKG215; UKG213; UKG220; UKG222; UKG225; UKG233; UKG248; UKG260; ULG308; ULG305; ULG289; ULG285; ULG281; ULG278; ULG272; ULG271; ULG269; ULG331; ULG321; ULG317; ULG315; ULG344; ULG343; ULG346; ULG352; ULG371; ULG368; ULG365; ULG361; ULG359; ULG341; ULG390; ULG392; ULG394; ULG396; UMG432; UMG427; ULG413; UMG438; UMG445; UMG472; UMG471; UMG459; UMG456; UMG455; UMG476; UMG493; UMG505; UMG509; UHG005; UHG019; UHG022; UHG034; UHG043; UHG044;    PCDL1 ----- UMG489; UMG483; UMG468; UMG451; UMG431; ULG408; UMG429; UMG430; ULG398; ULG397; ULG381; ULG339; ULG354; ULG355; ULG306; ULG319; ULG332; ULG193; ULG298; ULG279; ULG275; UKG255; UKG229; UKG227; UKG226; UKG168; UKG173; UKG178; UJG117; UJG094; UHG053; UHG069; UJG080; UHG060; UJG073; UHG048;   PCDH1 ----- UMG475; UMG481; UMG494; UMG436; UMG437; UMG454; UMG458; UMG457; UMG423; UMG433; UMG414; UMG415; ULG375; ULG376; ULG377; ULG391; ULG406; ULG372; ULG349; ULG348; ULG336; ULG327; ULG310; ULG304; ULG300; ULG288; ULG276; UKG265; UKG252; UKG218; UKG219; UKG230; UKG217; UKG205; UKG204; UKG186; UKG174; UKG167; UKG163; UJG157; UJG145; UJG143; UJG141; UJG127; UJG100; UJG098; UJG115; UJG114; UJG108; UJG084; UGG997; UGG998; UHG013; UHG030; UHG039;    PCDB1 ------ ULG323; ULG296; UEG886; UEG884; UJG116; UJG108; UJG104; UJG089; UJG079; UHG065; UJG076; UHG067; ULG296; UEG884; UEG886; UJG116; UJG104; UJG106; UJG089; UJG079; UHG065; UJG076; UHG067; ULG296; UEG884; UEG886; UJG116; UJG104; UJG106; UJG089; UJG079; UHG065; UJG076; UHG067; ULG323; ULG296; UEG884; UEG886; UJG116; UJG104; UJG106; UJG079; UJG089; UHG065; UJG076; UHG067;  PCDG1 ----- UMG482; UMG498; UMG499; UMG500; UMG441; UMG469; UMG470; UMG442; UMG447; UMG446; ULG402; UMG416; UMG419; UMG420; UMG421; UMG422; ULG384; ULG386; ULG387; ULG395; ULG356; ULG366; ULG367; ULG338; ULG329; ULG326; ULG325; ULG274; ULG334; ULG307; ULG299; ULG294; ULG288; ULG284; ULG283; UKG258; UKG259; UKG263; ULG277; UEG885; UKG234; UKG244; UKG245; UKG254; UKG196; UKG210; UKG197; UKG191; UKG193; UKG162; UKG179; UKG180; UJG146; UJG148; UJG153; UJG159; UJG132; UJG130; UJG124; UJG121; UJG105; UJG113; UJG091; UJG086; UJG083; UHG012; UHG063; UHG061; UHG047; UHG071; UHG064; UHG058; UHG055; UHG002; UHG003; UHG011; UHG017; UHG027; UHG036; UHG037; UHG041; UHG042; UHG045;   PCDT1 ----- UMG488; UMG485; UMG491; UMG452; UMG453; UMG435; ULG407; ULG410; UMG417; UMG428; UMG434; ULG363; ULG364; ULG389; ULG345; ULG357; ULG358; ULG291; ULG273; UKG257; UKG236; UKG221; UKG208; UKG209; UKG192; UKG171; UJG137; UJG111; UJG074; UHG057; UHG051; UHG020; UHG032; UHG033; UHG049;   PCDR1 ----- UMG487; UMG502; UMG474; UMG480; ULG333; ULG347; ULG301; ULG290; ULG282; UKG228; UKG237; UKG240; UKG195; UKG172; UJG147; UJG150; UJG140; UJG138; UJG136; UJG123; UJG102; UJG093; UJG090; UHG070; UHG062; UHG046; UHG052; UGG996; UHG006; UHG008; UHG009; UHG010; UHG016; UHG028;   PCDW1 ----- UMG495; UMG496; UMG444; UMG443; ULG412; UMG418; ULG378; ULG388; ULG380; ULG379; ULG360; ULG320; ULG297; ULG292; ULG280; UKG261; UKG251; UKG247; UKG189; UEG887; UKG206; UKG202; UKG188; UJG120; UJG151; UJG133; UHG029; UHG050;   PCDJ1 ------- UMG484; UMG497; UMG439; UMG440; ULG383; ULG382; ULG403; ULG404; ULG362; ULG353; ULG350; ULG351; ULG330; ULG314; ULG312; UKG238; ULG303; ULG318; ULG270; ULG268; UKG262; UKG246; UKG235; UKG232; UKG199; UKG212; UKG211; UKG200; UKG199; UKG185; UKG194; UKG182; UKG165; UKG164; UJG155; UJG152; UJG119; UJG165; UJG118; UJG112; UJG097; UJG081; UHG066; UGG990; UHG007; UHG015; UHG018;
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    There is a total of 1,070 consignees that have received recall product divided between hospitals and distributors nationwide. The product has been distributed internationally to the following countries: Argentina, Australia, Austra, Brazil, Canada, Chile Colombia, Czechoslovakian Republic, France, Germany Greece, Guaynabo, Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Panama, Poland, Portugal, Puerto Rico, Republic of Yemen, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirate, United Kingdom, Venezuela. Government shipments include: Alaska Area Native Health, Anchorage, AK; Audie L. Murphy VA Hospital, San Antonio, TX; VA Warehouse, Sioux Falls, SD; VA Medical Center, Miami, FL; Edward Hines Jr. VA Hospital, Hines, IL; J.L. McClellan VA Med. Ctr, Little Rock, AR; Medical Supply Warehouse, Andrews AFB, MD; Mike O''Callaghan Fed. Hospit, Neillis AFB, NV; Naval Medical Ctr., Portsmouth, VA; Recv Officer Hanal Hosp, Jacksonville, FL; USAF Academy Hospital, USAF Academy, CO; USAF Hospital Elmendorf, Elmendorf AFB, AK; VA Bay Pines, Saint Petersburg, FL; VA Hosp. Supply Service, Dallas, TX; VA Louisville, Louisville, KY; VA Med. Center WTS, Indianapolis, IN; VA Med. Ctr., Huntington, WV; VA Med. Ctr., Los Angeles, CA; VA Med. Ctr., Buffalo, NY; VA Med. Ctr., San Juan, PR; VA Med. Ctr, East Orange, NJ; VA Med. Ctr., New York, NY; VA Med. Ctr., Kansas City, MO; VA Med. Ctr., Leavenworth, KS; VA Med. Ctr., Wichita, KS; VA Med. Ctr., Temple, TX; VA Med. Ctr., Amarillo, TX; VA Med. Ctr., Grand Junction, CO; VA Med. Ctr., Nashville, TN; VA Med. Ctr., Mountain Home, TN; VA Med. Ctr., Loma Linda, CA; VA Med. Ctr., Wilmington, DE; VA Med. Ctr., Salisbury, NC; VA Med. Ctr., Columbia, MO; VA Med. Ctr., Saint Louis, MO; VA New York Harbor Healthcare, Brooklyn, NY; WHMC/MSLS, Lackland AFB, TX; Womack Army, Fort Bragg, NC.
  • Description du dispositif
    PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is comprised of an oxidized regenerated cellulose (ORC) fabric, and PROLENE Soft Mesh, a nonabsorbable polypropylene mesh, which is encapsulated by a polydioxanone polymer. The polypropylene mesh side of the product allows for tissue ingrowth while the ORC side provides a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue and organ surfaces during the wound-healing period to minimize tissue attachment to the mesh. The polydioxanone provides a bond to the ORC layer.
  • Manufacturer
    Ethicon, Inc.

Manufacturer

Ethicon, Inc.
  • Adresse du fabricant
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA