CLASS III Device recall · Reported 26 Mar 2014 · FDA Enforcement Report

Endobon Xenograft Granules (Bovine bone substitute) Endobon recalled

Biomet 3i is recalling Endobon Xenograft Granules (Bovine bone substitute) Endobon is a bone substitute of, distributed in 13 states. The recall was initiated on 3 Oct 2013 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesModel # ROX05, Batch # S0171051

Quantity recalled704

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1233-2014
FDA event ID: 67194
Recalling firm: Biomet 3i, Palm Beach Gardens, FL
Classification: Class III
Status: Terminated
Recall initiated: 3 Oct 2013
FDA classified: 19 Mar 2014
Reported: 26 Mar 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

3 Oct 2013	Recall initiated by company
19 Mar 2014	Classified by FDA	+167 days
26 Mar 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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.

California District of Columbia Florida Hawaii Louisiana Massachusetts Missouri North Carolina New Jersey New York Texas Virginia Washington

Questions about this recall

Why was it 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 lots are affected?

Model # ROX05, Batch # S0171051

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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