FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
- Recall number
- Z-1393-2023
- Recalling firm
- Smith & Nephew, Inc.
- Product
- JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
- Status
- Open, Classified
- Initiated
- 2023-03-27
- Posted
- 2023-04-14
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 12 units
- Distribution
- US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.
- Lot, serial or model codes
- Catalog Number: 74026178; UDI/DI: 00885556677209; Batch Number: 22CAP0038R; Lot Number: 22CAP0038R
- 510(k) numbers
- K190085
- PMA numbers
- not on file
- Product code
- HSX
- Firm FEI
- 1020279
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28