Devices

Device Recall Zimmer

  • Model / Serial
    lot no.: 61873094 61895696 61905916 61905918 61905920 61919766 61919767 61919768 61956249 61956250 61981202 61981204 61999375 62027331 62060784 62074467 62074469 62096750 62096751 62133740 62164984 62168517 62171693 62171694 62171696 62174936 62205101 62213332 62213333 62220943 62345691 62345692 62345693 62345694 62352447 62352450
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    Product 48 consists of all product under product code: JWH and same usage: || Item no: || 597206526 NEXGEN ALL-POLY PATELLA, || for use in total knee arthroplasty
  • Manufacturer
    Zimmer Manufacturing B.V.
  • 1 Event

Manufacturer

Zimmer Manufacturing B.V.
  • Manufacturer Address
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 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 M/L Taper Hip Prosthesis, 7711 Series
  • Model / Serial
    Lot Number: 63716611; UDI: (01)00889024131736(17)270731(10)63716611
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the following U.S. states: AZ, CA, CT, IN, MD, MI, MN, NJ, NY, OR, WA, and Puerto Rico. Distributed in China and India.
  • Product Description
    Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset Reduced Neck Length; Part Number: 00-7711-007-40
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall Zimmer M/L Taper Hip Prosthesis, 7711 Series
  • Model / Serial
    Lot Number: 63716613, UDI: (01)00889024131606(17)270731(10)63716613; Lot Number: 63716614, UDI: (01)00889024131606(17)279731(10)63716614
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the following U.S. states: AZ, CA, CT, IN, MD, MI, MN, NJ, NY, OR, WA, and Puerto Rico. Distributed in China and India.
  • Product Description
    Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ZIMMER PATELLOFEMORAL JOINT PROSTHESIS
  • Model / Serial
    00-5926-011-01 Knee PFJ FEM, CEMENTED, SZ 1, LEFT  00-5926-012-01 Knee PFJ FEM, CEMENTED, SZ 2, LEFT  00-5926-013-01 Knee PFJ FEM, CEMENTED, SZ 3, LEFT  00-5926-013-02 Knee PFJ FEM, CEMENTED, SZ 3, RIGHT 00-5926-014-02 Knee PFJ FEM, CEMENTED, SZ 4, RIGHT 00-5926-015-02 Knee PFJ FEM, CEMENTED, SZ 5, RIGHT
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
  • Product Description
    PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ || Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ZIMMER PATELLOFEMORAL JOINT PROSTHESIS
  • Model / Serial
    00-5926-014-02 Knee PFJ FEM, CEMENTED, SZ 4, RIGHT
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
  • Product Description
    ZIMMER PATELLA FEMORAL JOINT¿ || Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ZIMMER UNICOMPARTMENTAL KNEE SYSTEM
  • Model / Serial
    00-5842-012-02 61777606 00-5842-012-02 61774093 00-5842-013-01 61774095 00-5842-013-02 61777611 00-5842-014-01 11002921 00-5842-014-01 61777613 00-5842-014-02 61777615 00-5842-014-02 61777616 00-5842-015-01 61777617 00-5842-016-02 61756843
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
  • Product Description
    ZUK PRC FEM SZB RMED/LLAT¿ || ZUK PRC FEM SZC LMED/RLAT¿ || ZUK PRC FEM SZC RMED/LLAT¿ || NGU PRC FEM SZD LMED/RLAT¿ || ZUK PRC FEM SZD RMED/LLAT¿ || ZUK PRC FEM SZE LMED/RLAT || ZUK PRC FEM SZF RMED/LLAT || " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
  • Manufacturer
    Zimmer Biomet, Inc.
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