Ethicon, Inc.: 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.

Recall number

Z-0449-06

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.

Status

Terminated

Initiated

2006-01-04

Posted

2006-01-26

Terminated

2006-09-28

Reason

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.

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

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.

Lot, serial or model codes

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;

510(k) numbers

["K031925"]

PMA numbers

not on file

Product code

FTL

Firm FEI

2210968

Firm city

Somerville

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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