Recall Z-0401-2013— Kerr Corporation

Class II FDA medical device recall by Kerr Corporation, initiated 2012-10-25, terminated 2013-09-23. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process..

Recalling firm

Kerr Corporation

Classification

Class II

Status

Terminated

Initiated

2012-10-25

Terminated

2013-09-23

Firm location

Orange, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.