RBT — Class II medical device recall Z-0391-2016
Terminated recall by BioHorizons Implant Systems Inc, reported 2015-12-16, distributed in AZ, CA, CO, GA, MD, MI, NC, NY…. An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packagin
| Recall number | Z-0391-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioHorizons Implant Systems Inc, Hoover, AL, United States |
| Recall initiated | 2015-10-30 |
| Classified | 2015-12-07 |
| Reported by FDA | 2015-12-16 |
| Terminated | 2016-02-04 |
| Distributed | AZ, CA, CO, GA, MD, MI, NC, NY, OH, WA |
| Countries outside the US | IR |
| Quantity | 32 units |
| Reason classes | labeling |
| Lot numbers | 1404442 |
| Model numbers | LPBR5015 |
Product
RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
Reason for recall
An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
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-0391-2016. 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.