Device Recall Zimmer

  • Modèle / numéro de série
    lot no.: 62207450
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Product 35 consists of all product under product code: JWH and same usage: || Item no: || 522007300 I/B II KNEE FLUTED ROD, 1 || 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
    Part number 00-0965-002-01
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CT, FL, HI, IL, KY, MA, MD, MN, MO, NE, NJ, NY, OH, OK, PA, TN, TX, WA, and WI; and country of Canada.
  • Description du dispositif
    Zimmer Patient Helper Bed Frame Adapter Assembly || The bed frame adapter assembly is intended to be used by qualified medical professionals to adapt a patient helper to a hospital bed. The patient helper is used to aid and assist the patient's mobility within a hospital bed and during bed ingress and egress.
  • Manufacturer
  • Modèle / numéro de série
    Item No. 47-2358-107-11; Lots 61803307, 61969598, and 62084127 Item No. 47-2358-107-15; Lot 61825319
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Internationally Distributed in China only.
  • Description du dispositif
    ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM || DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT || RIGHT 11 HOLES 178 MM LENGTH || STERILE RX ONLY || Product Usage: Usage: || The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: Comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions.
  • Manufacturer
  • Modèle / numéro de série
    Part Number Range:00-5842-011/017-01/02
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
  • Description du dispositif
    Zimmer¿ Unicompartmental Knee Femoral Component. || Indicated for patients with painful and/or disabling knee joint.
  • Manufacturer
  • Modèle / numéro de série
    Item #'s:  00-2347-001-12 00-2347-001-14 00-2347-001-16 00-2347-001-18 Lot #s: All lots with an expiration date prior to July 24, 2023
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    FEM COND BUTTRESS PLT, RT.
  • Manufacturer
  • Modèle / numéro de série
    Item Numbers:  47-2357-101-14 47-2357-101-18 47-2357-102-14 47-2357-102-18 All lots with an expiration date prior to July 24, 2023
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    DIST LAT FEM LOCK PLT, RT
  • Manufacturer
258 en plus