JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
FDA device recall Z-1393-2023 · posted 2023-04-14 · Open, Classified
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- Reason for recall
- 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.
- Action taken
- Smith & Nephew notified consignees via email and overnight mail on 03/27/2023. Consignees were instructed to immediately review inventory and quarantine any affected units, notify customers if the product was further distributed, complete and return the response form and arrange for the return of affected units.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- HSX
- Quantity affected
- 12 units
- Distribution
- US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.
- Date initiated
- 2023-03-27
- Date posted
- 2023-04-14
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Journey II Unicompartmental Knee System (K190085) | Smith & Nephew, Inc. | 2019-02-11 |