Recall Z-0401-2013
Kerr Corporation · initiated October 25, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
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: Labeling design
Action taken
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 18005377123 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.
Details
- Recall number
- Z-0401-2013
- Initiated
- October 25, 2012
- Posted by FDA
- November 20, 2012
- Terminated
- September 23, 2013
- Product code
- LYC – Bone Grafting Material, Synthetic
- Quantity
- 22,410 units
- Distribution
- Worldwide Distribution - USA (nationwide) Canada, Europe, Australia and ROW consignees .
- Recalling firm
- Kerr Corporation, Orange, CA