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Recall Observatory FDA recall evidence

Device product

ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery.

Z-1233-2014

October 03, 2013

Class III

Product summary

Firm
Biomet 3i, LLC
Event
Event 67194
Status
Terminated
Classification
Class III
Quantity
704
Official record key
device-enforcement:Z-1233-2014

Official wording

Reason: Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number.

Code information: Model # ROX05, Batch # S0171051

Distribution pattern: Worldwide Distribution - USA including CA, DC, FL, LA, MA, MO, NC, NJ, NY, TX, VA, WA and Hawaii and Internatially to Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Great Britain (UK), Ireland, Mexico, Poland, Portugal, and Singapore.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    label with the wrong