Kerr Recalls BioPlant Dental Bone Grafting Material Due to Ossification Delay
Kerr Corporation is recalling BioPlant dental bone grafting material because disturbing the product may halt or delay the ossification process.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where the hazard is the potential to halt or delay the ossification process, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Kerr Corporation is recalling 22,410 units of BioPlant, a synthetic dental bone grafting material. BioPlant is a Class II Medical Device intended for 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 firm initiated the recall because disturbing the BioPlant product soon after it is placed may halt or delay the ossification process. The affected products include BioPlant Curved Syringes in 0.125g, 0.25g, and 0.50g sizes, as well as BioPlant Intro Packs. Specific part numbers and lot numbers are listed in the agency's structured data, with some lots affecting all production and others affecting lots within shelf-life.
The product was distributed worldwide, including nationwide in the USA, Canada, Europe, Australia, and other regions. Consumers and healthcare providers who have used or possess this product should contact their healthcare provider or the recalling firm for instructions on how to proceed.
The recalled product
- 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 i
- Manufacturer
- Kerr Corporation
- Hazard
- Affected units
- 22,410
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 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
Distribution
Distributed nationwide across the United States.
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