Z-1233-2014Class III

ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin...

Name: Z-1233-2014 ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin...
Creator: Biomet 3i, LLC
Published: 2013-10-03
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2013-10-03 / Terminated / root cause: labeling and UDI

FDA source

Biomet 3i, LLC began a recall of ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or... on 2013-10-03. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1233-2014
Classification: Class III
Status: Terminated
Initiated: 2013-10-03
Posted: 2014-03-19
Terminated: 2014-12-11
Recalling firm: ZimVie US Corp LLC
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.
Product code: LYC Bone Grafting Material, Synthetic
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.
Root cause tag: labeling and UDI
FDA 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. Customer were also instructed to respond to the attached Response Form via fax at 561-514-6316 or email to: [email protected]. For any questions or concerns, call Biomet 3i Customer Service at 1-800-342-5454. For questions regarding this recall call 561-776-6706.
Quantity in commerce: 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.
Product codes and lots: Model # ROX05, Batch # S0171051

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1233-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1233-2014	Class III	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-19

Product code LYC

K980679Class IIEndobonBiomet, Inc. / cleared 1998-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)