Device Recall Zimmer

  • Modèle / numéro de série
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Product 53 consists of all product under: product code: JWH and same usage: || Item no: || 597002501 NEXGEN PRECOAT PEG TIB PL || 597002502 NEXGEN PRECOAT PEG TIB PL || 597003501 NEXGEN PRECOAT PEG TIB PL || 597003502 NEXGEN PRECOAT PEG TIB PL || 597004501 NEXGEN PRECOAT PEG TIB PL || 597004502 NEXGEN PRECOAT PEG TIB PL || 597005501 NEXGEN PRECOAT PEG TIB PL || 597005502 NEXGEN PRECOAT PEG TIB PL || 597005503 NEXGEN PRECOAT PEG TIB PL || 597005504 NEXGEN PRECOAT PEG TIB PL || 598002701 NEXGEN PRECOAT STEMMED TI || 598002702 NEXGEN PRECOAT STEMMED TI || 598003701 NEXGEN PRECOAT STEMMED TI || 598003702 NEXGEN PRECOAT STEMMED TI || 598004701 NEXGEN PRECOAT STEMMED TI || 598004702 NEXGEN PRECOAT STEMMED TI || 598005701 NEXGEN PRECOAT STEMMED TI || 598005702 NEXGEN PRECOAT STEMMED TI || 598005703 NEXGEN PRECOAT STEMMED TI || 598005704 NEXGEN PRECOAT STEMMED TI || 598801510 NEXGEN SHARP FLUTED STEM || 598801511 NEXGEN SHARP FLUTED STEM || 598801512 NEXGEN SHARP FLUTED STEM || 598801513 NEXGEN SHARP FLUTED STEM || 598801514 NEXGEN SHARP FLUTED STEM || 598801515 NEXGEN SHARP FLUTED STEM || 598801516 NEXGEN SHARP FLUTED STEM || 598801517 NEXGEN SHARP FLUTED STEM || 598801518 NEXGEN SHARP FLUTED STEM || 598801519 NEXGEN SHARP FLUTED STEM || 598801520 NEXGEN SHARP FLUTED STEM || 598801010 NEXGEN STRAIGHT STEM EXT || 598801011 NEXGEN STRAIGHT STEM EXT || 598801012 NEXGEN STRAIGHT STEM EXT || 598801013 NEXGEN STRAIGHT STEM EXT || 598801014 NEXGEN STRAIGHT STEM EXT || 598801015 NEXGEN STRAIGHT STEM EXT || 598801016 NEXGEN STRAIGHT STEM EXT || 598801017 NEXGEN STRAIGHT STEM EXT || 598801018 NEXGEN STRAIGHT STEM EXT || 598801020 NEXGEN STRAIGHT STEM EXT || 598801022 NEXGEN STRAIGHT STEM EXT || 598801024 NEXGEN STRAIGHT STEM EXT || 598801112 NEXGEN STRAIGHT STEM EXT || 598801113 NEXGEN STRAIGHT STEM EXT || 598801114 NEXGEN STRAIGHT STEM EXT || 598801115 NEXGEN STRAIGHT STEM EXT || 598801116 NEXGEN STRAIGHT STEM EXT || 598801117 NEXGEN STRAIGHT STEM EXT || 598801118 NEXGEN STRAIGHT STEM EXT || 598801212 NEXGEN STRAIGHT STEM EXT || 598801215 NEXGEN STRAIGHT STEM EXT || for use in total knee arthroplasty
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA

263 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Lot P020077.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    The product was shipped to Hawaii, New York, South Carolina, and South Dakota in the United States.
  • Description du dispositif
    Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Only the Trinica Bone Tap Instruments are being recalled from the sets.
  • Manufacturer
  • Modèle / numéro de série
    Lots 60244776, 60254445, 60270467, 60278638, 60298344, 60317739, 60330363 and 60342788.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • Description du dispositif
    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 45 degrees, non-sterile; Part number 00-7712-035-01.
  • Manufacturer
  • Modèle / numéro de série
    Lots 60244777, 60254446, 60259343, 60280558, 60295662, 60298480, 60307612, 60333170 and 60336853.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • Description du dispositif
    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; Part number 00-7712-035-02.
  • Manufacturer
  • Modèle / numéro de série
    Lots 08686700 and 08686500.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • Description du dispositif
    Zimmer M/L Taper Rasp Handle, Left, 45 degrees, non-sterile; Part number 83-7712-035-01. Recall Z-0671-06 extended to include this product.
  • Manufacturer
  • Modèle / numéro de série
    Lots 08686600 and 08686800.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • Description du dispositif
    Zimmer M/L Taper Rasp Handle, Right, 45 degrees, non-sterile; Part number 83-7712-035-02. Recall Z-0671-06 extended to include this product.
  • Manufacturer
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