Device Recall Surgical bur

  • Model / Serial
    OEM Catalog number 5820-10-240.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in DC and the states of CO, CA, FL, TX, and AR.
  • Product Description
    Medical Device Exchange Round Fluted Bur Aggressive; 4.0mm; || Pouch, Tyvek/Mylar, Sterile, Single Use Only; || OEM Catalog number 5820-10-240; || EXP (repackager), Stryker (OEM) || Drills, burrs, trephines & accessories || (simple, powered)
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    EXP Pharmaceutical Services Corp, 48021Warm Springs Boulevard, Fremont CA 94539
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

4 devices with a similar name

Learn more about the data here

  • Model / Serial
    OEM Catalog number 5820-10-120.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in DC and the states of CO, CA, FL, TX, and AR.
  • Product Description
    Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; || Pouch, Tyvek/Mylar, Sterile, Single Use Only; || OEM Catalog number 5820-10-120; || EXP (repackager), Stryker (OEM) || Drills, burrs, trephines & accessories || (simple, powered)
  • Manufacturer
  • Model / Serial
    OEM Catalog number 5820-10-130.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in DC and the states of CO, CA, FL, TX, and AR.
  • Product Description
    Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; || Pouch, Tyvek/Mylar, Sterile, Single Use Only; || OEM Catalog number 5820-10-130; || EXP (repackager), Stryker (OEM) || Drills, burrs, trephines & accessories || (simple, powered)
  • Manufacturer
  • Model / Serial
    OEM Catalog number 5820-10-160.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in DC and the states of CO, CA, FL, TX, and AR.
  • Product Description
    Medical Device Exchange 6.0mm Round Fluted Bur Soft Touch; || Pouch, Tyvek/Mylar, Sterile, Single Use Only; || OEM Catalog number 5820-10-160; || EXP (repackager), Stryker (OEM) || Drills, burrs, trephines & accessories || (simple, powered)
  • Manufacturer
  • Model / Serial
    OEM Catalog number A-CRN-S.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in DC and the states of CO, CA, FL, TX, and AR.
  • Product Description
    Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; || Pouch, Tyvek/Mylar, Sterile, Single Use Only; || OEM Catalog number A-CRN-S; || EXP (repackager), Anspach (OEM) || Bur, surgical, general & plastic surgery
  • Manufacturer