FDA-Device2012-11-28Class II
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 preservatio
Kerr Corporation
Hazard
The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process.
Sold states
Worldwide Distribution - USA (nationwide) Canada, Europe, Australia and ROW consignees .
Affected count
22,410 units
Manufactured in
1717 W Collins Ave, N/A, Orange, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0401-2013Don't want to check this manually?
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