ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bov...
FDA Device Recall #Z-1233-2014 — Class III — October 3, 2013
Recall Summary
| Recall Number | Z-1233-2014 |
| Classification | Class III — Low risk |
| Date Initiated | October 3, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Biomet 3i, LLC |
| Location | Palm Beach Gardens, FL |
| Product Type | Devices |
| 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.
Lot / Code Information
Model # ROX05, Batch # S0171051
Other Recalls from Biomet 3i, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0075-2021 | Class II | CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference ... | Aug 31, 2020 |
| Z-0078-2021 | Class II | CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Ref... | Aug 31, 2020 |
| Z-0076-2021 | Class II | CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference ... | Aug 31, 2020 |
| Z-0077-2021 | Class II | CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Refer... | Aug 31, 2020 |
| Z-0073-2021 | Class II | BellaTek Encode Defin3DPMSERitive Abutments-3D ... | Aug 31, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.