🔍 RecallPedia

INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic

Class I - Dangerous
🏥 Medical Devices Recalled: May 28, 2013 Medtronic Sofamor Danek USA Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lots: M111103AAG, M111052AAQ, M111052AAR, M111052AAP, M111052AAL, M111059AAC, M111059AAF, M111052AAF, M111059AAH, M111103AAB, M111059AAG, M111052AAK, M111052AAJ, M111059AAB, M111059AAK, M111052AAI, M111052AAO, M111052AAH, M111052AAG, M111059AAD
  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:
Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic

Product Codes/Lot Numbers:

Lots: M111103AAG, M111052AAQ, M111052AAR, M111052AAP, M111052AAL, M111059AAC, M111059AAF, M111052AAF, M111059AAH, M111103AAB, M111059AAG, M111052AAK, M111052AAJ, M111059AAB, M111059AAK, M111052AAI, M111052AAO, M111052AAH, M111052AAG, M111059AAD

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1592-2013

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