BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone...
FDA Device Recall #Z-0401-2013 — Class II — October 25, 2012
Recall Summary
| Recall Number | Z-0401-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 25, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Kerr Corporation |
| Location | Orange, CA |
| Product Type | Devices |
| Quantity | 22,410 units |
Product Description
BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant is a synthetic, multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery, ridge preservation, ridge augmentation, augmentations in the maxillary sinus, repair of periodontal defects and bone voids associated with dental implant placement.
Reason for Recall
The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process.
Distribution Pattern
Worldwide Distribution - USA (nationwide) Canada, Europe, Australia and ROW consignees .
Lot / Code Information
The BioPlant part numbers and lot numbers affected by this recall are as follows: Product Description Part Numbers Lot Numbers BioPlant Curved Syringe, 0.125g 216110 All Production BioPlant Curved Syringe, 0.25g 216112 BioPlant Curved Svrinoe, 0.50<1 216114 Lots Within Shelf-Life BioPlant Curved Svrinoe, 0.250 216132 20k BioPlant Intro Pack 216112S
Other Recalls from Kerr Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1788-2014 | Class II | Tytin Regular Set, Double Spill, 50 Capsules, P... | May 29, 2014 |
| Z-0414-2013 | Class II | The brand name of the device is Laser Loupes, a... | Apr 10, 2012 |
| Z-0268-2013 | Class II | The brand name of the device is AlgiNot, a dent... | Feb 21, 2012 |
| Z-0402-2013 | Class II | Freedom Cordless LED Light System. Freedom Syst... | Nov 17, 2011 |
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.