Forza 89-0103
Forza 89-0103 is a Class II device made by Orthofix US LLC, cleared under FDA 510(k) K103111 on 23 Mar 2011 and listed in FDA GUDID since 17 Jul 2026 (UDI-DI 18257200076888), 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 | Number18257200076888 | Date17 Jul 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK103111 | Date23 Mar 2011 | StatusActive |
Official records
- AccessGUDID record 18257200076888
- FDA 510(k) database K103111
Across registries
- FDA 510(k) K103111 decided 23 Mar 2011 Active
- FDA GUDID UDI-DI 18257200076888 listed 17 Jul 2026 Listed
Recalls
-
- Terminated Z-1037-2012
The 8mm and 10mm Rotating Cutters may fracture during use, specifically during disc space preparation. If an 8mm or 10mm Rotating Cutter does Fracture during use, it may result in a surgical delay estimated to be 30 minutes or greater due to preparing the disc space using other instruments or methods and/or retrieving the instrument fragment.
Timeline
- Cleared FDA 510(k) K103111
- Recall initiated FDA recalls Z-1037-2012
- Listed FDA GUDID 18257200076888
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Forza
- Generic name
- Orthopaedic inorganic implant inserter/extractor, reusable
- Model / reference
- 89-0103
- Primary DI / UDI-DI
- 18257200076888
- 510(k) Number
- FDA product code
- MAX
- GMDN term
- Orthopaedic inorganic implant inserter/extractor, reusable
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution