Journey 74016412
Journey 74016412 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K190085 on 11 Feb 2019 and listed in FDA GUDID since 13 Jun 2019 (UDI-DI 00885556690031), active as of 23 Oct 2026. 3 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00885556690031 | Date13 Jun 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190085 | Date11 Feb 2019 | StatusActive |
Official records
- AccessGUDID record 00885556690031
- FDA 510(k) database K190085
Across registries
- FDA 510(k) K190085 decided 11 Feb 2019 Active
- FDA GUDID UDI-DI 00885556690031 listed 13 Jun 2019 Listed
Recalls
-
- Ongoing Z-1393-2023
A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.
-
- Terminated Z-2133-2020
- Terminated Z-2132-2020
The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.
Timeline
- Cleared FDA 510(k) K190085
- Listed FDA GUDID 00885556690031
- Recall initiated FDA recalls Z-2133-2020
- Recall initiated FDA recalls Z-2132-2020
- Recall initiated FDA recalls Z-1393-2023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Journey
- Generic name
- Orthopaedic reamer guide
- Model / Ref / Catalog
- 74016412
- Description
- JOURNEY II UK RESECTION ANTERIOR/POSTERIOR BLOCK RIGHT MEDIAL/LEFT LATERAL SZ 2
- Primary DI / UDI-DI
- 00885556690031
- 510(k) Number
- FDA product code
- HSX
- GMDN term
- Orthopaedic reamer guide
- Device class
- Class II
- Regulation number
- 888.3520
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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