Devices

Device Recall Zimmer

  • Model / Serial
    Item numbers: 01.01012.384; 01.01012.385; 01.01012.386; 01.01012.387; 01.01012.388; 01.01012.444; 01.01012.445; 01.01012.446; 01.01012.447; 01.01012.448   Lot #'s: 2551762, 2542690, 2542691, 2543993, 2544892, 2544893, 2551930, 2551931, 2557054, 2558475, 2559787, 2563363, 2564657, 2568082, 2539887, 2540911, 2544894, 2544895, 2545830, 2545831, 2545832, 2545833, 2547043, 2547807, 2548952, 2551330, 2551860, 2551861, 2554798, 2554799, 2554800, 2558476, 2558477, 2559788, 2561617, 2562662, 2563364, 2563385, 2565407, 2566564, 2567294, 2542692, 2542693, 2544896, 2547044, 2548953, 2551932, 2553210, 2556029, 2559603, 2563386, 2539888, 2540926, 2548954, 2553419, 61487633, 61487634, 61636015, 61495961, 61495962, 61495963, 61562431, 61577697, 61608436, 61562432, 61577709, 61487635, 61562448
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan
  • Product Description
    CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
  • Manufacturer
    Zimmer Gmbh
  • 1 Event

Manufacturer

Zimmer Gmbh
  • Manufacturer Address
    Zimmer Gmbh, Sulzer Allee 8, Winterthur Switzerland
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • 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

Device Recall Zimmer Anatomical Shoulder Glenoid
  • Model / Serial
    Lot 2385941.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Maryland.
  • Product Description
    Zimmer Anatomical Shoulder Prosthesis, Glenoid, Cemented, sterile; REF 01.04214.370.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer
  • Model / Serial
    Lot No: 60646894.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan.
  • Product Description
    Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Left, 45 degrees, non-sterile; REF/Catalog #: 7712-35-01, Zimmer U.K. Ltd., SN3, 4FP, UK
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer
  • Model / Serial
    Lot No: 60651168 and 60726506.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan.
  • Product Description
    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; REF 7712-35-02, Zimmer U.K. Ltd., SN3, 4FP, UK
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer Hemovac Wound Drainage Device Infection Control Kits
  • Model / Serial
    Lot Numbers: 60009294, 60075254, 60101562, 60156041, 60215686, 60271994, 60314032, 60389073, 60440024, 60506573 and 60590575.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide-USA, Australia, Canada, Colombia, Denmark, Dubai, Italy, Japan, Mexico and Singapore.
  • Product Description
    Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF: 00-2550-001-10, 400 ml INF. Cntrl. Kit w/ 3/32" drain, 2.4 mm, 7Fr, PVC, 107 cm, small, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer H.A.S. Autotransfusion System H.A.S. Kit with 1/8" Drain
  • Model / Serial
    All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
  • Product Description
    Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/8" Drain , 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-020-05.
  • Manufacturer
    Zimmer Inc.
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