BioPlant — Class II medical device recall Z-0401-2013
Terminated recall by Kerr Corporation, reported 2012-11-28, distributed nationwide. The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay
| Recall number | Z-0401-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kerr Corporation, Orange, CA, United States |
| Recall initiated | 2012-10-25 |
| Classified | 2012-11-20 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2013-09-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Quantity | 22,410 units |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0401-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.