510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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Z-0449-06

PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh designed for the repair of hernias and other...

Ethicon, Inc / initiated 2006-01-04 / Terminated
FDA source (opens on fda.gov)

Ethicon, Inc. began a recall of PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is... on . The reason FDA records is "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...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0449-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Ethicon, Inc
Product
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.
Product code
FTL Mesh, Surgical, Polymeric
Reason for recall
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.
FDA root cause
Other
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.
Quantity in commerce
18,270 devices
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.
Product codes and lots
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;