Device Recall Stryker rHead Lateral Stem

  • Modelo / Serial
    's="" 22288701,="" 22629401,="" 22891001,="" 23199201,="" 23425201="" 23917401; part="" number:(lateral="" 3) lot="" 15886,="" 22288801,="" 22629501,="" 22891101,="" 23199301,="" 23425301,="" 23917501="" 23917502; part="" 310-0010="" (lat="" rad="" stem="" 4) lot="" 15887,="" 23199401,="" 23425401,="" 23917601="" 19458-s2; part="" 310-0011="" impl="" 16708,="" 16709,="" 22629601,="" 22891201="" 23425501; part="" 310-0012="" 16710,="" 16711,="" 22629701,="" 22891301="" 23425601; part="" 310-0013="" 16712="" 23425701; part="" 310-2010="" (rhead="" implant="" plasma="" coated,="" size1) lot="" 22552401,="" 19693-s2,="" 19742-s2="" 19799-s2; part="" 310-2011="" 22552501,="" 19694-s2="" 19743-s2; part="" 310-2012="" 22552601,="" 19070-s2,="" 19695-s2,="" 19744-s2="" 19800-s2; part="" 310-2013="" 22552701,="" 19696-s2="" 19745-s2; part="" 310-2014="" 6mm="" collar,="" 1) lot="" 22552801,="" 22552802,="" 19697-s2,="" 19698-s2="" 19746-s2; part="" 310-2015="" 22552901,="" 19699-s2,="" 19747-s2="" 19915-s2; part="" 310-2016="" 22553001,="" 19700-s2="" 19748-s2; part="" 310-2017="" #22553101; part="" 310-2018="" recon="" 1)="" lot="" 22553201,="" 22889801,="" 19701-s2,="" 19749-s2="" 19801-s2; part="" 310-2019="" 22553301,="" 22889901,="" 19702-s2,="" 19750-s2,="" 19916-s2="" 19975-s2; part="" 310-2020="" 22553401,="" 22890001,="" 19703-s2,="" 19751-s2,="" 19802-s2="" 19976-s2; part="" 310-2021="" 22553501,="" 22890101,="" 197076-s2,="" 19704-s2,="" 19752-s2,="" 19917-s2="" 19977-s2; part="" 310-2022="" 22553601,="" 22890201,="" 197501-s2="" 19753-s2; part="" 310-2023="" 22553701,="" 22890301,="" 19706-s2="" 19754-s2; part="" 310-2024="" 22553801,="" 22890401,="" 19075-s2,="" 19707-s2="" 19755-s2; part="" 310-2025="" #'s22553901,="" 22890501="" 19071-s2;  part="" 410-0100="" standard="" extended=""  lot="" 18527,="" 18724,="" 19681-s2="" 19715-s2; part="" 410-0101="" 18528,="" 18725,="" 19682-s2="" 19756-s2; part="" 410-0102="" 18529,="" 18726,="" 19663-s2="" 19757-s2; part="" 410-0103="" 18530,="" 18727,="" 19683-s2="" 19758-s2;  part="" rcn-s160="" non-coated,="" 18370,="" 18371,="" 18388,="" 18569,="" 18698,="" 18718="" 22614101,="" 22849001,="" 23068201,="" 19102-s2,="" 19103-s2,="" 19104-s2,="" 19717-s2,="" 19804-s2="" 19920-s2; part="" rcn-s260="" 18372,="" 18373,="" 18699,="" 18719,="" 18840,="" 22614301,="" 22849201,="" 23068401,="" 19105-s2,="" 19106-s2,="" 19107-s2,="" 19773-s2,="" 19851-s2="" 19984-s2; part="" rcn-s360="" 18570,="" 18571,="" 18700,="" 18701,="" 18702,="" 18755,="" 18841,="" 1884222298301,="" 22298302,="" 22849401,="" 23479801,="" 19108-s2,="" 19723-s2,="" 19807-s2,="" 19854-s2,="" 19986-s2="" r23479801; part="" rcn-s460="" #'s18572,="" 18703,="" 18704,="" 18756,="" 18843,="" 18844,="" 22298401,="" 22614601,="" 22849601,="" 19109-s2="" 19110-s2; part="" rha-s160="" #''s="" 18375,="" 18386,="" 18501,="" 18707,="" 18708,="" 18848,="" 18849,="" 18850,="" 18851,="" 18852,="" 22613101,="" 22850101,="" 23069101,="" 19113-s2,="" 19114-s2,="" 19115-s2,="" 19779-s2="" 19809-s2; part="" rha-s260="" 18376,="" 18384,="" 18385,="" 18502,="" 18575,="" 18709,="" 18720,="" 18853,="" 18854,="" 22613301,="" 22850301,="" 23069301,="" 19116-s2,="" 19117-s2="" 19782-s2; part="" rha-s360="" 18377,18383,="" 18503,="" 18710,="" 18711,="" 18856,="" 18857,="" 18858,="" 18859,="" 22613501,="" 22850501,="" 19118-s2,="" 19119-s2,="" 19730-s2="" 19813-s2; part="" rha-s460="" 18379,="" 18382,="" 18504,="" 18576,="" 18712,="" 18713,="" 18860,="" 18861,="" 18862,="" 22613701,="" 22850701,="" 19120-s2="" 19121-s2"="" v-b-tooltip=""> Part Number: 310-0000 (Lateral Assembly, Radial Implant, Size 1) Lot #'s 22288301, 22890701, 23424401, 23916901, 19058-S2, 19452-S2, 19661-S2, 19662-S2, 19712-S2, 19736-S2 and 19841-S2; Part Number: 310-0001 (Lateral Assembly, Radial Implant, Size 2) Lot #'s 22629201, 22890801, 23424501, 23917001, 19453-S2, 19737-S2, 19765-S2, 19766-S2 and 19793-S2; Part Number:310-0002 (Lateral Assembly, Radial Stem Implant, Size 3) Lot #'s 22288401, 22629301, 23198901, 23434601, 23917101, 19678-S2, 19767-S2, 19768-S2, 19794-S2 and 19842-S2; Part Number: 310-0003 (Lateral Assembly, Radial Implant, Size 4) Lot #'s 22288501, 23199001, 23424701, 23917201, 19068-S2, 19679-S2, 19713-S2, 19738-S2, 19795-S2 and 19843-S2; Part Number: 310-0004 (Lat Assembly, Rad Stem Implant, Collar 6mm, Size1) Lot #'s 22288601, 23424801, 19057-S2, 19067-S2, 19454-S2, 19739-S2, 19796-S2 and 19844-S2; Part Number: 310-0005 (Lat Assembly, Rad Stem Implant, Collar 6mm, Size 2) Lot #'s 23424901, 23917301, 19063-S2, 19124-S2, 19455-S2, 19714-S2, 19740-S2 and 19797-S2; Part Number: 310-0006 (Lat Assembly, Rad Stem Implant, Collar 6mm, size 3) Lot #'s 23199101, 23425001, 19059-S2, 19680-S2, 19741-S2, 19798-S2 and 19845-S2; Part Number: 310-0007 (Lat Assembly, Rad Stem Implant, Collar 6mm, size 4) Lot #"s 22890901, 2345101, 19060-S2, 19125-S2 and 19457-S2; Part Number: 310-0008 (Lateral Assembly, Radial Head Implant, Size 2) Lot #'s 22288701, 22629401, 22891001, 23199201, 23425201 and 23917401; Part Number:(Lateral Assembly, Radial Head Implant, Size 3) Lot #'s 15886, 22288801, 22629501, 22891101, 23199301, 23425301, 23917501 and 23917502; Part Number: 310-0010 (Lat Assembly, Rad Stem Head Implant, Size 4) Lot #'s 15887, 23199401, 23425401, 23917601 and 19458-S2; Part Number: 310-0011 (Lateral Assembly, Radial Head Impl Assembly, Size 2) Lot #'s 16708, 16709, 22629601, 22891201 and 23425501; Part Number: 310-0012 (Lateral Assembly, Radial Head Impl Assembly, Size 3) Lot #'s 16710, 16711, 22629701, 22891301 and 23425601; Part Number: 310-0013 (Lateral Assembly, Radial Head Impl Assembly, Size 4) Lot #'s 16712 and 23425701; Part Number: 310-2010 (rHead Stem Implant Plasma Coated, Size1) Lot #'s 22552401, 19693-S2, 19742-S2 and 19799-S2; Part Number: 310-2011 (rHead Stem Implant Plasma Coated, Size 2) Lot #'s 22552501, 19694-S2 and 19743-S2; Part Number: 310-2012 (rHead Stem Implant Plasma Coated, Size 3) Lot #'s 22552601, 19070-S2, 19695-S2, 19744-S2 and 19800-S2; Part Number: 310-2013 (rHead Stem Implant Plasma Coated, Size 4) Lot #'s 22552701, 19696-S2 and 19745-S2; Part Number: 310-2014 (rHead Stem Implant 6mm Collar, Size 1) Lot #'s 22552801, 22552802, 19697-S2, 19698-S2 and 19746-S2; Part Number: 310-2015 (rHead Stem Implant 6mm Collar, Size 2) Lot #'s 22552901, 19699-S2, 19747-S2 and 19915-S2; Part Number: 310-2016 (rHead Stem Implant 6mm Collar, Size 3) Lot #'s 22553001, 19700-S2 and 19748-S2; Part Number: 310-2017 (rHead Stem Implant 6mm Collar, Size 4) Lot #22553101; Part Number: 310-2018 (rHead Recon Stem Implant Plasma Coated, Size 1) Lot #'s 22553201, 22889801, 19701-S2, 19749-S2 and 19801-S2; Part Number: 310-2019 (rHead Recon Stem Implant Plasma Coated, Size 2) Lot #'s 22553301, 22889901, 19702-S2, 19750-S2, 19916-S2 and 19975-S2; Part Number: 310-2020 (rHead Recon Stem Implant Plasma Coated, Size 3) Lot #'s 22553401, 22890001, 19703-S2, 19751-S2, 19802-S2 and 19976-S2; Part Number: 310-2021 (rhead Recon Stem Implant Plasma Coated, Size 4) Lot #'s 22553501, 22890101, 197076-S2, 19704-S2, 19752-S2, 19917-S2 and 19977-S2; Part Number: 310-2022 (rHead Recon Stem Implant 6mm Collar, Size 1) Lot #'s 22553601, 22890201, 197501-S2 and 19753-S2; Part Number: 310-2023 (rHead Recon Stem Implant 6mm Collar, Size 2) Lot #'s 22553701, 22890301, 19706-S2 and 19754-S2; Part Number: 310-2024 (rHead Recon Stem Implant 6mm Collar, Size 3) Lot #'s 22553801, 22890401, 19075-S2, 19707-S2 and 19755-S2; Part Number: 310-2025 (rHead Recon Stem Implant 6mm Collar, Size 4) Lot #'s22553901, 22890501 and 19071-S2;  Part Number: 410-0100 (rHead Standard Extended Stem 6mm Collar, Size 1)  Lot #'s 18527, 18724, 19681-S2 and 19715-S2; Part Number: 410-0101 (rHead Standard Extended Stem 6mm Collar, Size 2) Lot #'s 18528, 18725, 19682-S2 and 19756-S2; Part Number: 410-0102 (rHead Standard Extended Stem 6mm Collar, Size 3) Lot #'s 18529, 18726, 19663-S2 and 19757-S2; Part Number: 410-0103 (rHead Standard Extended Stem 6mm Collar, Size 4) Lot #'s 18530, 18727, 19683-S2 and 19758-S2;  Part Number: RCN-S160 (rHead Recon Stem Implant Non-Coated, Size 1) Lot #'s 18370, 18371, 18388, 18569, 18698, 18718 22614101, 22849001, 23068201, 19102-S2, 19103-S2, 19104-S2, 19717-S2, 19804-S2 and 19920-S2; Part Number: RCN-S260 (rHead Recon Stem Implant Non-Coated, Size 2) Lot #'s 18372, 18373, 18699, 18719, 18840, 22614301, 22849201, 23068401, 19105-S2, 19106-S2, 19107-S2, 19773-S2, 19851-S2 and 19984-S2; Part Number: RCN-S360 (rHead Recon Stem Implant Non-Coated, Size 3) Lot #'s 18570, 18571, 18700, 18701, 18702, 18755, 18841, 1884222298301, 22298302, 22849401, 23479801, 19108-S2, 19723-S2, 19807-S2, 19854-S2, 19986-S2 and R23479801; Part Number: RCN-S460 (rHead Recon Stem Implant Non-Coated, Size 4) Lot #'s18572, 18703, 18704, 18756, 18843, 18844, 22298401, 22614601, 22849601, 19109-S2 and 19110-S2; Part Number: RHA-S160 (rhead Radial Implant 6mm Collar, Size 1) Lot #''s 18375, 18386, 18501, 18707, 18708, 18848, 18849, 18850, 18851, 18852, 22613101, 22850101, 23069101, 19113-S2, 19114-S2, 19115-S2, 19779-S2 and 19809-S2; Part Number: RHA-S260 (rhead Radial Implant 6mm Collar, Size 2) Lot #'s 18376, 18384, 18385, 18502, 18575, 18709, 18720, 18853, 18854, 22613301, 22850301, 23069301, 19116-S2, 19117-S2 and 19782-S2; Part Number: RHA-S360 (rhead Radial Implant 6mm Collar, Size 3) Lot #'s 18377,18383, 18503, 18710, 18711, 18856, 18857, 18858, 18859, 22613501, 22850501, 19118-S2, 19119-S2, 19730-S2 and 19813-S2; Part Number: RHA-S460 (rhead Radial Implant 6mm Collar, Size 4) Lot #'s 18379, 18382, 18504, 18576, 18712, 18713, 18860, 18861, 18862, 22613701, 22850701, 19120-S2 and 19121-S2
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA