Devices

zimmer Anatomical Shoulder

  • Model / Serial
    REF Numbers: 01.04215.072, 01.04215.092, 01.04215.122, 01.04215.142. , 01.04217.072, 01.04217.132 Lot 2398402, 2485014, 2347028, 2347028, 2380422, 2348099, 2341901,  2435527, 2398475
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and || Anatomical Shoulder Fracture Humeral stem
  • Manufacturer
    Zimmer, Inc.
  • 1 Event

Manufacturer

Zimmer, Inc.
  • Manufacturer Address
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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

3 devices with a similar name

Learn more about the data here

Device Recall Zimmer Anatomical Shoulder Handle for Rasp
  • Model / Serial
    Lot Number(s):  13870129 &  13878179.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed to the states of IN, GA, WI, MO, PA, KS, TN, and NY.
  • Product Description
    Anatomical Shoulder Handle for Rasp || Item: 01.04233.000 || Used during total joint arthroplasty of the shoulder.
  • Manufacturer
    Zimmer Gmbh
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.
zimmer Anatomical Shoulder Glenoid S
  • Model / Serial
    REF Numbers: 01.04214.340, 01.04214.345, 01.04214.370, 01.04214.400, and 01.04214.405. Lot 2416527, 2430357, 2447460, 2450204, 2348311, 2348311, 2364768, 2364768, 2364768, 2403597, 2418592, 2418592, 2452946, 2453947, 2503319, 2503319, 2517200, 2329832, 2349655, 2388161, 2453280, 2453280, and 2533474.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340 || PE Keeled Glenoid S, cemented, sterile; REF 01.04214.345, || Glenoid M, cemented, sterile; REF 01.04214.370, || Glenoid L, cemented, sterile; REF 01.04214.400 || PE Keeled Glenoid L, cemented, sterile; REF 01.04214.405
  • Manufacturer
    Zimmer, Inc.