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U.S. Department of Health and Human Services

Class 2 Device Recall BioPlant

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 Class 2 Recall
BioPlant
see related information
Date Posted November 20, 2012
Recall Status1 Terminated on September 23, 2013
Recall Number Z-0401-2013
Recall Event ID 63557
Product Classification Bone Grafting Material, Synthetic - Product Code LYC
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.
Code Information The BioPlant part numbers and lot numbers affected by this recall are as follows: Product Description Part Numbers Lot Numbers BioPlant Curved Syringe, 0.125g 216110 All Production BioPlant Curved Syringe, 0.25g 216112 BioPlant Curved Svrinoe, 0.50<1 216114 Lots Within Shelf-Life BioPlant Curved Svrinoe, 0.250 216132 20k BioPlant Intro Pack 216112S
Recalling Firm/
Manufacturer
Kerr Corporation
1717 W Collins Ave
Orange, California 92867-5422
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process.
FDA Determined
Cause 2
DESIGN: 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. Customers were instructed to contact Kerr Customer Care at 1®800®537®7123 if they have any questions. Customers were also instructed to complete and fax back the enclosed Acknowledgement Form to 714-288-4609 in order to confirm their receipt of this correction regardless of whether they have any affected product in their inventory. For questions regarding this recall call 714-516-7400.
Quantity in Commerce 22,410 units
Distribution Worldwide Distribution - USA (nationwide) Canada, Europe, Australia and ROW consignees .
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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