Na 2359-14-45
by Zimmer, Inc.
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00889024057463 | Date27 Jun 2016 | StatusListed |
Recalls
-
- Terminated Z-0646-2016
Product on the package label did not match what was inside the package. The label was for part number 00-2359-058-35 (Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58mm Length) lot number 62918019 while the product inside the package was part number 00-2359-014-24 (Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14mm Length) lot number 62896038.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic Name
- Orthopaedic bone screw (non-sliding)
- Model / Ref / Catalog
- 2359-14-45, 00-2359-014-45
- Primary DI / UDI-DI
- 00889024057463
- 510(k) Number
- FDA Product Code
- HWC, HRS
- GMDN Term
- Orthopaedic bone screw (non-sliding)
- Device Class
- Class II
- Regulation Number
- 888.3040, 888.3030
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
- Size
- Length — 14 Millimeter
Other devices from Zimmer, Inc.
Properties
Other properties (10)
- Sterile: No
- Contains Latex: 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