PlainRecalls
FDA Devices Low Class III Terminated

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.

Reported: March 26, 2014 Initiated: October 3, 2013 #Z-1233-2014

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
Biomet 3i, LLC
Units Affected
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.
Location
Palm Beach Gardens, FL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Biomet 3i, LLC. Units affected: 704.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 26, 2014. Severity: Low. Recall number: Z-1233-2014.