Device Recall Maxim

  • Model / Serial
    Lots 692030, 847270, 893240, 991260, 103470, 103440, 136560, 271330, 170710, 356500, 399630, 399640, 564090, 712190, 744790, 757850, 770410, 994540 and 863650.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Austria, Belgium, Canada, Costa Rica, Denmark, Finland, Greece, Israel, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, and the United Kingdom.
  • Product Description
    Biomet Maxim SI knee instruments sliding femoral 4-in-1 block, 60 mm, stainless steel; Ref. RD140530.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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

151 devices with a similar name

Learn more about the data here

  • Model / Serial
    Catalog No. CL60-100; Known Lot No. NHS160219.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution - US including CA and VA.
  • Product Description
    PALLAS M/MAXIMIS Large Crosslink. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
  • Model / Serial
    Catalog No. CR60-030; Lot No. Unknown.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution - US including CA and VA.
  • Product Description
    PALLAS M/MAXIMIS 5.5 x 05mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
  • Model / Serial
    Catalog No. C060-050; Known Lot No. WNV110516
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution - US including CA and VA.
  • Product Description
    PALLAS M/MAXIMIS 50mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
  • Model / Serial
    Catalog No. C060-060; Known Lot No. WNV110516
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution - US including CA and VA.
  • Product Description
    PALLAS M/MAXIMIS 60mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
  • Model / Serial
    Catalog No. 0902-1007. Unknown Lot No.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution - US including CA and VA.
  • Product Description
    PALLAS M/MAXIMIS 5.5 mm Instrument Tap. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
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