🔍 RecallPedia

Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE LP reusable instruments are intended for the surgical implantation of the PRESTIGE LP Cervical Disc. Medtronic reusable instruments must be sterilized prior to initial use and must be cleaned and sterilized prior to each re-use.

Class I - Dangerous
🏥 Medical Devices Recalled: March 13, 2018 Medtronic Sofamor Danek USA Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    a) REF 6975205, 5mm; UDI 00643169752979 Lot Number ID17K018 b) REF 6975206, 6mm; UDI 00643169752962 Lot Number ID17J009 c) REF 6975207, 7mm; UDI 00643169752955 Lot Numbers: ID17K007, ID17L035
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Medtronic Sofamor Danek USA Inc
Reason for Recall:
The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill bit breakage.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE LP reusable instruments are intended for the surgical implantation of the PRESTIGE LP Cervical Disc. Medtronic reusable instruments must be sterilized prior to initial use and must be cleaned and sterilized prior to each re-use.

Product Codes/Lot Numbers:

a) REF 6975205, 5mm; UDI 00643169752979 Lot Number ID17K018 b) REF 6975206, 6mm; UDI 00643169752962 Lot Number ID17J009 c) REF 6975207, 7mm; UDI 00643169752955 Lot Numbers: ID17K007, ID17L035

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1641-2018

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