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Kerr Corporation recalls BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Syn
Recalled November 28, 2012 · FDA recall Z-0401-2013 · Kerr
Hazard
The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process. · FDA Class II
Units
22,410 units
Sold at
Worldwide Distribution - USA (nationwide) Canada, Europe, Australia and ROW consignees .
Description
The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process.
Product
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.
Manufacturer(s)
Kerr Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →