RecallRadar

FDA Device recall Z-1233-2014

ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for imp…

On 2014-03-26 the FDA classified a Class III recall of ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for imp… by Biomet 3i, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1233-2014
ClassificationClass III
Statusterminated
Initiated2013-10-03
Published2014-03-26
Last updated2026-09-13 11:53 UTC
CompanyBiomet 3i
DistributionCA, DC, FL, HI, LA, MA, MO, NC, NJ, NY, TX, VA, WA

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.

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.

Identifiers

code_infoModel # ROX05, Batch # S0171051

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1233-2014%22

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