Zimmer® Natural Nail™ System 00-2490-081-43
by Zimmer, Inc.
Ref 00-2490-081-43
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 | Number889024SHKR 00889024276611 | Date19 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00889024276611 | Date24 Sep 2016 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
-
- Terminated Z-1793-2021
- Terminated Z-1792-2021
Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree
-
- Terminated Z-0337-2020
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
-
- Terminated Z-0119-2016
In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. If a compromised packaging is not detected prior or during a surgery by the user, it may lead to periprosthetic infection. This may result in revision or multi-stage revision to treat the infection.
-
- Terminated Z-0824-2011
The firm has determined that two lots of this instrument were inappropriately manufactured by the supplier. The manufacturing process created a step in the lumen which impedes the Lag Screw Retaining Shaft from passing through the lumen without the use of excessive force.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Zimmer® Natural Nail™ System
- Generic Name
- General internal orthopaedic fixation system implantation kit
- Device Name
- Zimmer® Natural Nail™ System ZNN™, CMN sleeve
- Model / Ref / Catalog
- 00-2490-081-43
- Primary DI / UDI-DI
- 00889024276611
- Basic UDI-DI
- 889024SHKR
- Direct Marketing DI
- 00889024276611
- FDA Product Code
- HSB
- EMDN Code
- L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
- GMDN Term
- General internal orthopaedic fixation system implantation kit
- 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 |
Other devices from Zimmer, Inc.
Properties
Other properties (19)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Reprocessed: 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