Device Recall Stryker

  • Modèle / numéro de série
    Catalog No. 6541-4-808 Lot Nos.: SB1K14, SB1K14A, SB1K14A1, SB1K14P, SB1K15, SB1K15A, SB1K15A1, SB1K15A2, SB1M25, SB1M25A, SB1M25A1, SB1M25A2, SB1M25A2X1, SB1N02, SB1N02A, SB1N02A1, SB1N02A2, SB1N02A3, SB1N02X1, SB1T05, SB1T05A, SB1T05A1, SB1T05AX1, SB1T05AX2, SB1T05KSB1V01, SB1V01K, SB1V01L, SB1V01X1, SB1V01X2, SB1V01X3, SB1W14, SB1W14K, SB1W14X1, SB2T19, SB2T19A, SB2T19D, SB2T19DX1, SB2T19DX2, SB2T19J, SB2T19K, SB2T19KX1, SB2T19KX2, SBT19X3, SB2V87, SB2V87A, SB2V87J, SB2V87JX1, SB2V87K, SB2V87X, SB2V87X1, SB2W23, SB2W23G, SB2W23X, SB2W23X1, SB3A20, SB3A20A, SB3A21, SB3A21D, SB3A21M, SB3A21X, SB3A22, SB3A22A1, SB3A22X1, SB3A55, SB3A55A, SB3A55A2, SB3A55AX1, SB3A55M, SB3A55X1, SB3H25, SB3H25D, SB3H25G, SB3H25X1, SB3H26, SB3H26D, SB3H26DX1, SB3H26X2, SB3K09, SB3K09X1, SB3K10, SB3K10L, SB3K10M, SB3K10MX1, SB3K10X1, SB3L19, SB3L19D, SB3L19K, SB3L19L, SB3L19P, SB3L19P1, SB3L20, SB3L20K, SB3L45, SB3L45A, SB3L45A1, SB3L45A2, SB3L45D, SB3L45DX1, SB3L45L, SB3L45T, SB3M17, SB3M17A, SB3M17K, SB3M17M, SB3M18, SB3M18A, SB3M18AX1, SB3M18D, SB3M18M, SB3M18R, SB3M19, SB3M19A, SB3M19A1, SB3M19S, SB3M19T, SB3M19W, SB3N46, SB3N46D, SB3N46P, SB3N46X1, SB4C12, SB4C12X1, SB4C37, SB4C37X1, SB4C38, SB4C38A, SB4C38D, SB4E18, SB4E181, SB4E181X1, SB4E18A, SB4E18D, SB4E18T, SB4H79, SB4H79A, SB4H79M, SB4L05, SB4L05A, SB4N17, SB4N17E, SB4N17M, SB4N17M1, SB4N18, SB4N18A, SB4N18A1, SB4N18D, SB4N18M, SB4N18T, SB4S01, SB4S01D, SB4S01J, SB4V07, SB4V07L, SB4V07M, SB4V07MM, SB5A02, SB5A02A, SB5A02A1, SB5A55
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide
  • Description du dispositif
    Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S || Product Usage: || Is a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (TKA) system as well as the Triathlon Partial Knee Replacement (PKR) system. The use of the handles in Primary TKA is optional and may be used to: (1) Assist in stabilizing the Triathlon Femoral Sizer, (2) Aid in stabilization during use and removal of the Triathlon 4:1 Cutting Block and (3) Aid in assembly of the Anterior MIS Distal Resection Guide to the Anterior Skim Cut Guide. Per the Triathlon PKR surgical protocol, the handle is required for a PKR surgery and is used to: (1) Assemble and disassemble the Femoral Trial Drill Guide into the Femoral Trial and (2) Remove the Peg Trial from the Femoral Trial.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Société-mère du fabricant (2017)
  • Source
    USFDA

499 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Class I, 510(k) exempt  Catalog Number: 6543-1-600  Lot Number; NE1WR1
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    Stryker Orthopaedics || FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS || REF 6543-1-600;NON-STERILE || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430 USA || A Subsidiary of Stryker Corp. || Stryker France || ZAC Satolas Green Pusignan || Av de Satolas Green 69881 Meyzieu || Cedex France || The Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor, which allows for optimal bone coverage, compensating for differences between the Implant and bone canal axes. || Made in USA
  • Manufacturer
  • Modèle / numéro de série
    Class I, 510(k) exempt  Catalog Number: 6543-2-600  Lot Number: P1S43, P2A31
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    Stryker Orthopaedics || TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS || REF 6543-2-600;NON-STERILE || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430 USA || A Subsidiary of Stryker Corp. || Stryker France || ZAC Satolas Green Pusignan || Av de Satolas Green 69881 Meyzieu || Cedex France || Made in USA || The Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor, which allows for optimal bone coverage, compensating for differences between the Implant and bone canal axes.
  • Manufacturer
  • Modèle / numéro de série
    Manufacturer Part Number 2110-0505, Lot Numbers E909002 and E909002R
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
  • Description du dispositif
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 || Product Usage: || Facilitate placement of bone cement in weakened or diminished bone
  • Manufacturer
  • Modèle / numéro de série
    Manufacturer Part Number 2110-0526, Lot Numbers E908004R and E908004
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
  • Description du dispositif
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 || Product Usage: || Facilitate placement of bone cement in weakened or diminished bone
  • Manufacturer
  • Modèle / numéro de série
    Manufacturer Part Number 2090-0505, Lot Number A1006027
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
  • Description du dispositif
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 6", Part Number 2090-0505 || Product Usage: || Facilitate placement of bone cement in weakened or diminished bone
  • Manufacturer
494 en plus