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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

Product Description Bone products are derived from donated cadaver human tissue. They were prepared from tissue procured from a cadaver donor using aseptic surgical techniques. Each donor receives a Bacterin ID number, each graft from that donor receives a numeric graft ID. Individual grafts from the same donor will have the same base donor ID, but differing numeric graft ID's. Bacterin's product code and graft ID are placed on the finished product label.
Recall Number B-2147-12
Classification Class III
Code Info B100123201; B100123202; B100123203; B100123204; B100123205; B100123206; B100123207; B100123208; B100123209; B100123210; B100123215; B100123217; B100123218; B100123219; B100123220; B100123221; B100123222; B100123223; B100123224; B100123225; B100123226; B100123227; B100123228; B100123229; B100123230; B100123231; B100123232; B100123233; B100123234; B100123235; B100123236; B100123237; B100123238; B100123239; B100123240; B100123241; B100123242; B100123243; B100123244; B100123245; B100123246; B100123271; B100123281; B100123294; B100123295; B100123296; B100123297; B100123298; B100123801; B100123802; B100123803; B100123804; B100123805; B100123806; B100123808; B100123809; B100123812; B100123813; B100123814; B100123815; B100123816; B100123817; B100123818; B100123819; B100123820; B100123821; B100123822; B100123824; B100123825; B100123826; B100123827; B100123828; B100123829; B100123830; B100123831; B100123832; B100123833; B100123834; B100123835; B100123837; B100123839; B100123840; B100123841; B100123843; B100123844; B100123845; B100123846; B100124202; B100124203; B100124204; B100124207; B100124209; B100124211; B100124212; B100124213; B100124214; B100124215; B100124216; B100124217; B100124218; B100124219; B100124220; B100124223; B100124224; B100124225; B100124226; B100124234; B100124235; B100124236; B100124237; B100124238; B100124801; B100124802; B100124803; B100124804; B100124805; B100124807; B100124808; B100124810; B100124811; B100124812; B100124813; B100124814; B100124815; B100124816; B100124817; B100124818; B100124823; B100124824; B100124825; B100124826; B100124827; B100124828; B100124831; B100124832; B100124833; B100124834; B100124835; B100124836; B100124837; B100124838; B100124839; B100124840; B100124841; B100124842; B100124843; B100124844; B100124845; B100124846; B100124848; B100124849; B100124850; B100124851; B100124852; B100124853; B100124854; B100124855; B100124856; B100124857; B100124858; B100125201; B100125202; B100125203; B100125204; B100125205; B100125206; B100125207; B100125208; B100125209; B100125210; B100125211; B100125212; B100125213; B100125214; B100125215; B100125216; B100125217; B100125218; B100125219; B100125220; B100125221; B100125222; B100125223; B100125224; B100125226; B100125227; B100125228; B100125229; B100125230; B100125231; B100125232; B100125233; B100125234; B100125235; B100125236; B100125237; B100125239; B100125240; B100125241; B100125242; B100125243; B100125244; B100125245; B100125246; B100125247; B100125248; B100125249; B100125250; B100125251; B100125252; B100125253; B100125254; B100125255; B100125256; B100125257; B100125258; B100125259; B100125260; B100125261; B100125262; B100125263; B100125264; B100125265; B100125266; B100125267; B100125268; B100125269; B100125270; B100125271; B100125272; B100125273; B100125274; B100125275; B100125276; B100125277; B100125278; B100125283; B100125284; B100125702; B100125703; B100125704; B100125705; B100125706; B100125708; B100125709; B100125710; B100125712; B100125713; B100125714; B100125715; B100125720; B100125721; B100125723; B100125724; B100125725; B100125726; B100125727; B100125728; B100125729; B100125730; B100125730; B100125731; B100125732; B100125733; B100125734; B100125735; B100125736; B100125737; B100125738; B100125739; B100125740; B100125741; B100125742; B100125743; B100125744; B100125745; B100125746; B100125748; B100125749; B100125750; B100125751; B100125752; B100125753; B100125754; B100125755; B100125756; B100125761; B100125762; B100125763; B100125764; B100125765; B100125766; B100125767; B100125768; B100125769; B100125770; B100125771; B100125773; B100125774; B100125775; B100125776; B100125778; B100125779; B100125781; B100126201; B100126202; B100126203; B100126204; B100126205; B100126206; B100126207; B100126208; B100126209; B100126210; B100126211; B100126212; B100126213; B100126214; B100126215; B100126216; B100126217; B100126218; B100126219; B100126220; B100126221; B100126222; B100126223; B100126224; B100126227; B100126228; B100126229; B100126230; B100126231; B100126232; B100126233; B100126234; B100126235; B100126236; B100126237; B100126241; B100126242; B100126248; B100126249; B100126250; B100126252; B100126253; B100126254; B100126255; B100126256; B100126257; B100126264; B100126265; B100126266; B100126267; B100126269; B100127202; B100127203; B100127204; B100127205; B100127206; B100127207; B100127208; B100127210; B100127211; B100127212; B100127213; B100127214; B100127215; B100127216; B100127217; B100127218; B100127219; B100127220; B100127221; B100127222; B100127223; B100127224; B100127225; B100127226; B100127227; B100127228; B100127229; B100127230; B100127231; B100127232; B100127233; B100127234; B100127235; B100127236; B100127237; B100127238; B100127239; B100127240; B100127241; B100127243; B100127244; B100127245; B100127246; B100127247; B100127248; B100127249; B100127250; B100127251; B100127252; B100127253; B100127254; B100127255; B100127256; B100127257; B100127258; B100127259; B100127260; B100127261; B100127262; B100127263; B100127264; B100127265; B100127266; B100127267; B100127268; B100127269; B100127270; B100127271; B100127272; B100127273; B100127274; B100127275; B100127276; B100127277; B100127278; B100127279; B100127291; B100127292; B100127293; B100127294; B100141210; B100141211; B100141212; B100141214; B100141215; B100141216; B100141217; B100141218; B100141219; B100141220; B100141221; B100141222; B100141223; B100141230; B100141231; B100141234; B100141235; B100141236; B100141237; B100141238; B100141239; B100141240; B100141241; B100141242; B100141243; B100141244; B100141245; B100141246; B100141247; B100141248; B100141249; B100141250; B100141251; B100141253; B100141254; B100141255; B100141256; B100141257; B100141258; B100141260; B100141261; B100141262; B100141263; B100141264; B100141265; B100141266; B100141267; B100141268; B100141269; B100141270; B100141271; B100141272; B100141273; B100141274; B100141275; B100141276; B100141277; B100141278; B100141279; B100141280; B100141281; B100141282; B100141283; B100141284; B100141285; B100141286; B100141287; B100141288; B100141289; B100141290; B100141291; B100141292; B100141293; B100141294; B100141295; B100141296; B100141297; B100141298; B100141299; B100141300; B100141806; B100141808; B100141809; B100141810; B100141811; B100141814; B100141816; B100141817; B100141820; B100141821; B100141822; B100141823; B100141824; B100141826; B100141827; B100141828; B100141846; B100141847; B100141848; B100141849; B100141850; B100141851; B100141852; B100141853; B100141854; B100141855; B100141856; B100141858; B100141859; B100141860; B100141861; B100141862; B100141863; B100141864; B100141865; B100141866; B100141867; B100141868; B100141869; B100141870; B100141871; B100141872; B100141873; B100141874; B100141875; B100141876; B100142101; B100142201; B100142202; B100142203; B100142204; B100142205; B100142206; B100142209; B100142211; B100142212; B100142213; B100142214; B100142215; B100142216; B100142217; B100142218; B100142219; B100142220; B100142221; B100142222; B100142223; B100142224; B100142225; B100142227; B100142228; B100142229; B100142230; B100142231; B100142232; B100142233; B100142234; B100142235; B100142236; B100142237; B100142238; B100142239; B100142240; B100142241; B100142242; B100142243; B100142244; B100142246; B100142247; B100142248; B100142249; B100142250; B100142251; B100142252; B100142253; B100142254; B100142255; B100142256; B100142257; B100142258; B100142259; B100142260; B100142261; B100142262; B100142263; B100142264; B100142265; B100142266; B100142267; B100142268; B100142269; B100142270; B100142271; B100142272; B100142273; B100145215; B100145216; B100145217; B100145218; B100145221; B100145222; B100145223; B100145224; B100145225; B100145226; B100145227; B100145228; B100145230; B100145231; B100145232; B100145233; B100145234; B100145235; B100145236; B100145237; B100145238; B100145239; B100145240; B100145241; B100145242; B100145243; B100145244; B100145245; B100145246; B100145247; B100145248; B100145249; B100145250; B100145251; B100145252; B100145253; B100145254; B100145255; B100145256; B100145257; B100145258; B100145259; B100145260; B100145261; B100145263; B100145264; B100145265; B100145266; B100145267; B100145268; B100145269; B100145270; B100145273; B100145274; B100145275; B100145276; B100145277; B100145278; B100145279; B100145280; B100145281; B100145282; B100145283; B100145284; B100145285; B100145286; B100145287; B100145288; B100145289; B100145290; B100145291; B100145292; B100145293; B100145294; B100145295; B100145296; B100145297; B100145298; B100145299; B100145300; B100145501; B100145502; B100145503; B100145504; B100145505; B100145506; B100145507; B100145508; B100145509; B100145510; B100145801; B100145802; B100145803; B100145805; B100145805; B100145806; B100145807; B100145808; B100145809; B100145810; B100145811; B100145812; B100145813; B100145814; B100145815; B100145817; B100145818; B100145819; B100145820; B100145821; B100145822; B100145823; B100145824; B100145825; B100145826; B100145827; B100145828; B100145829; B100145830; B100145831; B100145832; B100145833; B100145834; B100145835; B100145836; B100145837; B100145838; B100145839; B100145840; B100145841; B100145842; B100145844; B100145845; B100145846; B100145847; B100145848; B100145849; B100145850; B100145851; B100145852; B100145853; B100145854; B100145855; B100145856; B100145857; B100145858; B100145859; B100145861; B100145862; B100145863; B100145865; B100145866; B100145867; B100145868; B100145869; B100145870; B100152101; B100152102; B100152201; B100152202; B100152203; B100152204; B100152206; B100152207; B100152208; B100152209; B100152210; B100152211; B100152212; B100152213; B100152214; B100152215; B100152216; B100152217; B100152219; B100152220; B100152221; B100152222; B100152223; B100152224; B100152225; B100152226; B100152227; B100152229; B100152230; B100152231; B100152232; B100152233; B100152234; B100152236; B100152240; B100152240; B100152242; B100152243; B100152244; B100152245; B100152246; B100152247; B100152248; B100152249; B100152251; B100152273; B100152274; B100152275; B100152276; B100152277; B100152278; B100152279; B100152281; B100152282; B100152283; B100152284; B100152285; B100152286; B100152291; B100152294; B100152300; B100152303; B100152304; B100153101; B100153102; B100153201; B100153202; B100153203; B100153204; B100153205; B100153206; B100153207; B100153208; B100153209; B100153210; B100153211; B100153212; B100153213; B100153214; B100153215; B100153216; B100153217; B100153218; B100153219; B100153220; B100153221; B100153222; B100153223; B100153224; B100153225; B100153226; B100153227; B100153228; B100153229; B100153230; B100153231; B100153232; B100153233; B100153234; B100153235; B100153237; B100153238; B100153239; B100153240; B100153241; B100153243; B100153244; B100153260; B100153270; B100153276; B100153277; B100153279; B100153280; B100153283; B100153284; B100153285; B100153286; B100153287; B100153288; B100153289; B100153290; B100153291; B100153292; B100153293; B100153294; B100153295; B100153296; B100153297; B100153298; B100153299; B100153300; B100153301; B100155101; B100155102; B100155104; B100155201; B100155202; B100155203; B100155204; B100155205; B100155207; B100155208; B100155209; B100155210; B100155211; B100155212; B100155213; B100155214; B100155215; B100155216; B100155217; B100155219; B100155220; B100155221; B100155222; B100155223; B100155224; B100155225; B100155226; B100155227; B100155228; B100155229; B100155230; B100155231; B100155232; B100155233; B100155234; B100155235; B100155236; B100155237; B100155238; B100155239; B100155240; B100155241; B100155242; B100155243; B100155244; B100155245; B100155246; B100155247; B100155248; B100155249; B100155250; B100155251; B100155252; B100155253; B100155254; B100155255; B100155256; B100155257; B100155258; B100155259; B100155260; B100155261; B100155262; B100155263; B100155274; B100155275; B100155276; B100155277; B100155278; B100155279; B100155878; B100155880; B100155881; B100155882; B100155883; B100155884; B100155885; B100155886; B100155889; B100155892; B100155895; B100155897; B100155898; B100159101; B100159103; B100159105; B100159105; B100159201; B100159202; B100159203; B100159204; B100159205; B100159206; B100159207; B100159208; B100159209; B100159210; B100159211; B100159212; B100159213; B100159216; B100159217; B100159218; B100159219; B100159220; B100159221; B100159222; B100159239; B100159240; B100159241; B100159242; B100159243; B100159244; B100159245; B100159246; B100159247; B100159248; B100159250; B100159251; B100159252; B100159253; B100159254; B100159255; B100159256; B100159257; B100159258; B100159259; B100159260; B100159261; B100159262; B100159263; B100159264; B100159265; B100159266; B100159269; B100159270; B100159273; B100159274; B100159275; B100159276; B100159277; B100159278; B100159279; B100159280; B100159281; B100159282; B100159283; B100159284; B100159285; B100187101; B100187102; B100187201; B100187202; B100187203; B100187205; B100187206; B100187207; B100187207; B100187208; B100187209; B100187210; B100187211; B100187212; B100187213; B100187214; B100187215; B100187216; B100187218; B100187227; B100187228; B100187229; B100187230; B100187231; B100187232; B100187233; B100187234; B100187235; B100187236; B100187237; B100187238; B100187239; B100187240; B100187241; B100187243; B100187244; B100187245; B100187246; B100187249; B100187250; B100187251; B100187252; B100187253; B100187254; B100187255; B100187256; B100187257; B100187258; B100187259; B100187260; B100187261; B100187262; B100187263; B100187264; B100187265; B100187266; B100187267; B100187268; B100187269; B100187270; B100187271; B100188201; B100188202; B100188203; B100188204; B100188205; B100188206; B100188207; B100188208; B100188209; B100188210; B100188211; B100188212; B100188215; B100188216; B100188217; B100188218; B100188220; B100188221; B100188222; B100188223; B100188224; B100188225; B100188228; B100188229; B100188230; B100188231; B100188232; B100188233; B100188234; B100188235; B100188236; B100188237; B100188238; B100188239; B100188246; B100189201; B100189202; B100189203; B100189204; B100189205; B100189206; B100189208; B100189209; B100189210; B100189211; B100189212; B100189213; B100189214; B100189215; B100189216; B100189217; B100189218; B100189219; B100189220; B100189221; B100189222; B100189223; B100189224; B100189225; B100189226; B100189227; B100189228; B100189229; B100189230; B100189231; B100189232; B100189233; B100189235; B100189236; B100189237; B100189238; B100189238; B100189239; B100189241; B100189242; B100189243; B100189244; B100189245; B100189246; B100189247; B100189251; B100189252; B100189253; B100189254; B100189255; B100189256; B100189257; B100189258; B100189259; B100189260; B100189261; B100189262; B100189263; B100189264; B100189265; B100189266; B100189267; B100189268; B100189269; B100189270; B100189271; B100189272; B100189273; B100189274; B100189275; B100189276; B100189277; B100189278; B100189279; B100189280; B100189281; B100189282; B100189284; B110002101; B110002205; B110002206; B110002207; B110002208; B110002209; B110002210; B110002211; B110002212; B110002213; B110002214; B110002215; B110002216; B110002217; B110002218; B110002219; B110002220; B110002221; B110002222; B110002223; B110002224; B110002225; B110002226; B110002227; B110002228; B110002229; B110002230; B110002231; B110002232; B110002233; B110002234; B110002235; B110002236; B110002237; B110002238; B110002239; B110002240; B110002245; B110002246; B110002247; B110002248; B110002249; B110002250; B110002252; B110002255; B110002256; B110002257; B110002258; B110002259; B110002260; B110002261; B110002262; B110002263; B110002274; B110002275; B110002276; B110002278; B110002279; B110002280; B110002286; B110002287; B110002292; B110002293; B110002294; B110002295; B110002296; B110002297; B110002298; B110002299; B110002300; B110024202; B110024203; B110024204; B110024205; B110024206; B110024207; B110024208; B110024209; B110024210; B110024211; B110024212; B110024213; B110024214; B110024215; B110024216; B110024217; B110024218; B110024219; B110024220; B110024221; B110024269; B110024270; B110024271; B110024272; B110024273; B110024274; B110024275; B110024276; B110024277; B110024278; B110024279; B110024280; B110024281; B110024282; B110024283; B110024284; B110024285; B110024286; B110024287; B110024288; B110024289; B110024290; B110024291; B110024292; B110024294; B110024295; B110024296; B110024297; B110024298; B110024299; B110024300; B110024301; B110024302; B110024303; B110024304; B110024305; B110024306; B110024307; B110024307; B110024309; B110024310; B110024311; B110024312; B110024313; B110024314; B110024315; B110024316; B110024317; B110024318; B110024319; B110024320; B110024321; B110024322; B110024323; B110024324; B110024325; B110024326; B110024327; B110024328; B110024329; B110024330; B110024331; B110024332; B110024333; B110024334; B110024335; B110024336; B110024337; B110024338; B110024339; B110024340; B110024341; B110024342; B110024343; B110024344; B110024345; B110024346; B110024347; B110024348; B110024349; B110024350; B110024351; B110024352; B110024353; B110024354; B110024361; B110024363; B110025201; B110025202; B110025204; B110025213; B110025214; B110025215; B110025220; B110025221; B110025222; 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Product Distributed Qty 2063 units
Reason For Recall Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.

Event Detail

Event Id 60075
Product Type Biologics
Status Ongoing
Recalling Firm Bacterin International Inc. Biologics Division
City Belgrade
State MT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-08-25
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distributed nationwide
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