Recall Z-1233-2014 ยท LYC Bone Grafting Material, Synthetic
Biomet 3i, LLC
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.
| Date | Mar 19, 2014 (initiated Oct 3, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Error in labeling |
| Action | Biomet 3i sent a Medical Advisory Notice dated October 3, 2013 via mail, facsimile or telephone to all affected customers. The notice identified the product, the problem, and the action to be taken by the customers. The customers were instructed to do the following: 1) Review their inventor for any incorrectly labeled products and return them to their local Biomet distributor. 2) Provide this information to persons in their organization that uses or order these products. 3) Ensure that a copy of this letter is provided to any other organization to which the products maybe have been transferred |
| Quantity | 704 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980679 | ENDOBON Biomet, Inc., Apr 3, 1998 |