Device Recall Zimmer

  • Model / Serial
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    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

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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