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Class 2 Device Recall BioPlant |
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Date Initiated by Firm |
October 25, 2012 |
Date Posted |
November 20, 2012 |
Recall Status1 |
Terminated 3 on September 23, 2013 |
Recall Number |
Z-0401-2013 |
Recall Event ID |
63557 |
Product Classification |
Bone grafting material, synthetic - Product Code LYC
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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 CA 92867-5422
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For Additional Information Contact |
714-516-7400
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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.
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FDA Determined Cause 2 |
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
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Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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