Biomet 3i, LLC: Medical Device Recall in 2014 - (Recall #: Z-1233-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: October 3, 2013

Date Posted: March 26, 2014

Recall Number: Z-1233-2014

Event ID: 67194

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.

Status: Terminated

Product Quantity: 704

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.

Voluntary or Mandated:

Voluntary: Firm initiated