Z-1233-2014 Class III Terminated
FDA device recall Z-1233-2014 was initiated by Biomet 3I, LLC on Oct 3, 2013 and is designated Class III. 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. The recall status is terminated (terminated Dec 11, 2014). Affected quantity: 704.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 26, 2014
- Initiation Date
- Oct 3, 2013
- Termination Date
- Dec 11, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 704
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.
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.
Code Information
Model # ROX05, Batch # S0171051
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1233-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026