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
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
label with the wrong