Reported Nov 28, 2012 · Terminated
BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material,…
Kerr Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Kerr Corporation · 1717 W Collins Ave · Orange, CA · 92867-5422
Is this the product you have?
- 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.
- Lot codes and dates
- The BioPlant part numbers and lot numbers
- affected by this recall are as followsProduct 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
- Amount recalled
- 22,410 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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