04.111.185
by Synthes
04.111.185 (04111185) is a Class II device made by Synthes, cleared under FDA 510(k) K081071 on 1 May 2008 and listed in FDA GUDID since 14 Sep 2015 (UDI-DI 10886982101181), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10886982101181 | Date14 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK081071 | Date1 May 2008 | StatusActive |
Official records
- AccessGUDID record 10886982101181
- FDA 510(k) database K081071
Across registries
- FDA 510(k) K081071 decided 1 May 2008 Active
- FDA GUDID UDI-DI 10886982101181 listed 14 Sep 2015 Listed
Recalls
-
- Terminated Z-0014-2014
A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential for bolt back-out or migration by emphasizing the need for supplemental fixation.
Timeline
- Cleared FDA 510(k) K081071
- Recall initiated FDA recalls Z-0014-2014
- Listed FDA GUDID 10886982101181
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Orthopaedic bone bolt
- Model / Ref / Catalog
- 04.111.185, 04111185
- Primary DI / UDI-DI
- 10886982101181
- 510(k) Number
- FDA product code
- HWC
- GMDN term
- Orthopaedic bone bolt
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization