Alloclassic

  • Model / Serial
    REF Numbers: 00-8775-028-01, 00-8775-028-02, 00-8775-028-03, 00-8775-032-01, 00-8775-032-02, 00-8775-032-03, 00-8775-032-04, 00-8775-036-01, 00-8775-036-02, 00-8775-036-03, 00-8775-036-04, 00-8775-040-01, 00-8775-040-02, 00-8775-040-03, and 00-8775-040-04.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Biolox¿ delta Ceramic Femoral Head || Rx only, sterile
  • Manufacturer
  • 1 Event

Manufacturer

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

5 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Non-active implants - bone surgery
  • Manufacturer
  • Model / Serial
    Item 2839, 2840, 2841, 2842, 2843, 2844, 2845, 2846, 2847, 2848, 2949, 2851, 2852, 2883, 2884, 2885, 2886, and 2887 Lots: 2359249, 2359251, 2359251, 2368739, 2413914, 2413914, 2426010, 2526138, 2335608, 2381324, 2387449, 2388541, 2401237, 2401237, 2492774, 2523553, 2355767, 2355767, 2361511, 2361511, 2371517, 2376476, 2440672, 2453100, 2479736, 2498363, 2529208, 2303302, 2347856, 2355765, 2355765, 2428247, 2428247, 2446699, 2456353, 2497037, 2506067, 2506067, 2509374, 2517494, 2316056, 2326792, 2335862, 2355428, 2370478, 2376478, 2382854, 2388539, 2391204, 2428742, 2431991, 2439733, 2453093, 2301633, 2343382, 2363829, 2363829, 2363829, 2370490, 2492887, 2513725, 2513725, 2513725, 2515404, 2515404, 2517796, 2529231, 2319316, 2340681, 2345324, 2359179, 2359179, 2413790, 2432646, 2479750, 2501280, 2509376, 2509376, 2509378, 2510392, 2510392, 2303201, 2333704, 2340906, 2368928, 2375002, 2388530, 2403651, 2445551, 2471087, 2507375, 2511623, 2523569, 2345382, 2396573, 2428657, 2432681, 2464083, 2469537, 2475899, 2529943, 2421855, 2421855, 2437494, 2437494, 2475746, 2475746, 2526284, 2391015, 2391015, 2391015, 2390171, 2418766, 2397095, 2399625, 2352268, 2406373, 2406373, 2437316, and 2518394
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Alloclassic SL Shaft
  • Manufacturer
  • Model / Serial
    REF Numbers: 01.00121.020, 01.00121.030, 01.00121.040, 01.00121.050, 01.00121.060, 01.00121.070, and 01.00121.090.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Alloclassic¿ SL-Offset Stem || sterile, Rx
  • Manufacturer