Z-0401-2013Class II

BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting...

Name: Z-0401-2013 BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting...
Creator: Kerr Corporation
Published: 2012-10-25
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2012-10-25 / Terminated / root cause: labeling and UDI

FDA source

Kerr Corporation began a recall of 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... on 2012-10-25. FDA classified it as Class II and gives the reason as "The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0401-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-25
Posted: 2012-11-20
Terminated: 2013-09-23
Recalling firm: Sybron Dental Specialties, Inc.
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.
Product code: LYC Bone Grafting Material, Synthetic
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.
Root cause tag: labeling and UDI
FDA root cause: 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 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.
Quantity in commerce: 22,410 units
Distribution: Worldwide Distribution - USA (nationwide) Canada, Europe, Australia and ROW consignees .
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0401-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0401-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-20

Product code LYC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)