Natural Nail®
Ref 00-2490-091-15
Active
Valid until
Not listed
FDA recalls
None ongoingDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number889024AE4Y8 00889024064676 | Date15 Oct 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00889024064676 | Date14 Jul 2016 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
-
- Terminated Z-2599-2017
Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
-
- Terminated Z-2060-2015
A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of implant prior to sufficient fracture healing, which may result in need for implant removal and revision of fracture fixation to assure proper healing and avoid fracture malunion or nonunion.
-
- Terminated Z-0380-2010
- Terminated Z-0379-2010
- Terminated Z-0386-2010
- Terminated Z-0387-2010
- Terminated Z-0384-2010
- Terminated Z-0377-2010
- Terminated Z-0375-2010
- Terminated Z-0383-2010
- Terminated Z-0376-2010
- Terminated Z-0382-2010
- Terminated Z-0388-2010
- Terminated Z-0378-2010
- Terminated Z-0381-2010
- Terminated Z-0385-2010
The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the threading method used.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device Name
- Zimmer Interlock
- Model / Ref / Catalog
- 00-2490-091-15
- Primary DI / UDI-DI
- 00889024064676
- Basic UDI-DI
- 889024AE4Y8
- 510(k) Number
- FDA Product Code
- HSB
- EMDN Code
- Z12021199 Orthopaedic endoscopy instruments - other
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 888.3020
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000001146
- Authorised representative
- Biomet Global Supply Chain Center B.V. NL-AR-000000422
Other devices from Zimmer, Inc.
Properties
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No