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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Event Detail

Event ID 63557
Product Type Devices
Status Ongoing
Recalling Firm Kerr Corporation
City Orange
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-25
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) Canada, Europe, Australia and ROW consignees .

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. The BioPlant part numbers and lot numbers affected by this recall are as follows: ├┐Product Description Part Numbers Lot Numbers SioPlant Curved Syringe, 0.125g 216110 All Production SioPlant Curved Syringe, 0.25g 216112 SioPlan! Curved Svrinoe, 0.50<1 216114 Lots Within Shelf-Life BioPlant Curved Svrinoe, 0.250 216132 20k BioPlant Intro Pack 216112S Class II The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process. 22,410 units Z-0401-2013
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