FEI 3009595577
Bioventus Llc
4721 Emperor Blvd Ste 100, Durham, NC, US
MDR events182All time
Recalls2All time
Registered products7
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
7 product codes
Recent MDR events
182 on file
- StimRouterJul 30, 2026Injury3027669735-2026-00004
- TalisMannJul 30, 2026Injury3027669735-2026-00003
- DUROLANE PRE-FILLED SYRINGEJul 20, 2026DeathMW5190840
- DUROLANEJul 16, 2026Injury3009595577-2026-00002
- TALISMANNJun 29, 2026Injury3027669735-2026-00001
- STIMROUTERJun 29, 2026Injury3027669735-2026-00002
- DUROLANEJun 8, 2026DeathMW5189013
- DUROLANE GEL INJECTIONSMay 6, 2026InjuryMW5187790
- DUROLANE GEL INJECTIONSMay 6, 2026InjuryMW5187791
- DUROLANEApr 11, 2026Injury3009595577-2026-00001
Recalls
2 on file
- TerminatedUnknown
Product may contain white particulates that are microbial in nature.
View FDA record ↗ - TerminatedUnknown
The firm became aware of the potential for the products' sterile pouch to be punctured during transit. The packaging failure may introduce a non-sterile device that may lead to patient infection.
View FDA record ↗
Compliance history
Matched by FEI 3009595577.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.