Recall Z-0401-2013 ยท LYC Bone Grafting Material, Synthetic
Kerr Corporation
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 bon
| Date | Nov 20, 2012 (initiated Oct 25, 2012) |
| Status | Terminated |
| Reason | The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process. |
| Root cause | Labeling design |
| Action | Kerr Corporation sent an Urgent Medical Device Correction letter and acknowledgement form dated October 25, 2012, to all affected customers via USPS First Class. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: "...review the table with product description , part numbers and lot numbers to determine if they have any of the affected product in their inventory and confirm that they were aware of the additional placement instructions necessary to achieve desired ossification results detailed in the paragraph in the letter. |
| Quantity | 22,410 units |
| Distribution | Worldwide Distribution - USA (nationwide) Canada, Europe, Australia and ROW consignees . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.