Device Recall Zimmer

  • Model / Serial
    lot no.: 61814292 61817008 61920896 61953528 62021071 62021071N 61810760 61814293 61817010 61830536 61868946 61895893 61920897 61953529 62021042 62079774 62326383 61810761 61810762 61817013 61817014 61830551 61895895 61895896 62079775 61810763 61810764 61817016 61830553 61850598 61917456 62173492 62173493 62286109 62318820 62326381 61814296 61920901 61830534 61830534N
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    Product 45 consists of all product under product code: JWH and same usage: || Item no: || 511007020 MGII KNEE SLF-TAP BONE ST || 511007025 MGII KNEE SLF-TAP BONE ST || 511007030 MGII KNEE SLF-TAP BONE ST || 511007035 MGII KNEE SLF-TAP BONE ST || 511007040 MGII KNEE SLF-TAP BONE ST || 511007045 MGII KNEE SLF-TAP BONE ST || for use in total knee arthroplasty
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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 devices with a similar name

Learn more about the data here

  • Model / Serial
    Catalog TMT4B10: Lot 61840378, 61960160, 61967093, 61982587
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • Product Description
    Zimmer Dental Trabecular Metal, TMT4B10 IMP TM 4.1MM MTX FULL,10MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA || The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region.(Catalog TMT indicates textured collar)
  • Manufacturer
  • Model / Serial
    Catalog # TMT4B11: Lot 61926103, 61960168, 61967139, 61978064, 61989032
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • Product Description
    Zimmer Dental Trabecular Metal, TMT4B11 IMP TM 4.1MM MTX FULL,11.5MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA || The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, Page 4 of 6 especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region.
  • Manufacturer
  • Model / Serial
    Catalog TMT4B13, lot 61926106, 61960169, 61967140, 61973165, 61985653
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • Product Description
    Zimmer Dental Trabecular Metal, TMT4B13 TM 4.1MM MTX FULL,13 MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA || The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. TMT catalog # indicates textured collar.
  • Manufacturer
  • Model / Serial
    Catalog TMM4B10, lot 6197019, 61971479, 61960143, 6180365, 6184063
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • Product Description
    Zimmer Dental Trabecular Metal, TMM4B10 TM 4.1MM MTX FULL,10 MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA || The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. Catalog TMM indicates machined collar.
  • Manufacturer
  • Model / Serial
    Catalog TMM4B11, lot 61926101, 61926107, 61960149, 619267162, 61992706
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • Product Description
    Zimmer Dental Trabecular Metal Implant, TMM4B11, 4.1mm x11.5 MM; 3.5 mm implant TM, MTX Rx, Sterile R, Zimmer Dental, Carlsbad, CA 92008, USA || The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. Catalog TMM indicates machined collar.
  • Manufacturer
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