Devices

Device Recall Anspach Single Use, Sterile Bone Cutting Burs

  • Model / Serial
    Lot #s, D343038845, D323038131
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including the states of CA, CO, IN, KY, MD and TX. and the countries of Germany, Japan, Taiwan, United Kingdom and Sweden.
  • Product Description
    Cutting Burr labeled in part:"***TURQ-434-4 QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. Use with B-TURQUOISE Attachment.***ANSPACH***Manufacturer Made in USA***The Anspach Effort, Inc***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel (800) 327 6887 / +1 561 627 1080***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe HP11 1LA***United Kingdom***Tel: +441494616126***Sterilized using Irradiation***Do Not Re-use***Keep Dry***Caution; consult accompanying documents***Sterile unless damaged or opened***Rx Only***" || Cutting and shaping bone including bones of the spine and cranium.
  • Manufacturer
    The Anspach Effort, Inc.
  • 1 Event

Manufacturer

The Anspach Effort, Inc.
  • Manufacturer Address
    The Anspach Effort, Inc., 4500 Riverside Drive, Palm Beach Gardens FL 33410-4235
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall Anspach Single Use, Sterile Bone Cutting Burs
  • Model / Serial
    Lot #s, D363039140, D323038110, D293037349
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including the states of CA, CO, IN, KY, MD and TX. and the countries of Germany, Japan, Taiwan, United Kingdom and Sweden.
  • Product Description
    Cutting Burr labeled in part:"***S-1504TD QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. Use with SHORT Attachments.***ANSPACH***Manufacturer Made in USA***The Anspach Effort, Inc***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel (800) 327 6887 / +1 561 627 1080***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe HP11 1LA***United Kingdom***Tel: +441494616126***Sterilized using Irradiation***Do Not Re-use***Keep Dry***Caution; consult accompanying documents***Sterile unless damaged or opened***Rx Only***". || Cutting and shaping bone including bones of the spine and cranium.
  • Manufacturer
    The Anspach Effort, Inc.