Device Recall APEX Hip System Bipolar Head

  • Model / Serial
    Lot Number: 5246
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- Including states of AZ, CA, CO, FL, IL, MI, NJ, OK, UT, VA, and WI.
  • Product Description
    Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 53 mm OD || Product Code: H3-82853. || Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Omni Life Science, 175 Paramont Drive, Raynham MA 02767
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

22 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot number: 5143
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- Including states of AZ, CA, CO, FL, IL, MI, NJ, OK, UT, VA, and WI.
  • Product Description
    Apex Hip System Bipolar Head, 22.225mm ID, 38 mm OD || Product Code: H3-82238. || Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.
  • Manufacturer
  • Model / Serial
    Lot Number : 5218
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- Including states of AZ, CA, CO, FL, IL, MI, NJ, OK, UT, VA, and WI.
  • Product Description
    Apex Hip System Bipolar Head, 22.225mm ID, 41 mm OD || Product Code: H3-82241. || Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.
  • Manufacturer
  • Model / Serial
    Lot Number: 5250
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- Including states of AZ, CA, CO, FL, IL, MI, NJ, OK, UT, VA, and WI.
  • Product Description
    Apex Hip System Bipolar Head, 22.225mm ID, 42 mm OD || Product Code: H3-82242. || Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.
  • Manufacturer
  • Model / Serial
    Lot Number : 5219
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- Including states of AZ, CA, CO, FL, IL, MI, NJ, OK, UT, VA, and WI.
  • Product Description
    Apex Hip System Bipolar Head, 22.225mm ID, 43 mm OD || Product Code: H3-82243. || Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.
  • Manufacturer
  • Model / Serial
    Lot NUmber :5147
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- Including states of AZ, CA, CO, FL, IL, MI, NJ, OK, UT, VA, and WI.
  • Product Description
    Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 44 mm OD || Product Code: H3-82844. || Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.
  • Manufacturer
17 more