JOURNEY recallZ-1393-2023 · Smith & Nephew, Inc. · initiated Mar 27, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smith & Nephew, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1393-2023
- Status
- Open, Classified
- Initiated by the company
- Mar 27, 2023
- Posted by the FDA
- Apr 14, 2023
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 12 units
- Product code
- HSX
- FDA submissions
- K190085
- Distribution
- US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.
Product description
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
Code information (models, lots, serial numbers)
Catalog Number: 74026178; UDI/DI: 00885556677209; Batch Number: 22CAP0038R; Lot Number: 22CAP0038R
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- JOURNEY 74026178Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall1 report
Product lines
Other devices under the same FDA submission
49 devices cleared under K190085 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- JOURNEY 74036058Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- JOURNEY 74026168Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- JOURNEY II UNI 74036039Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- JOURNEY 74036059Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- JOURNEY II UNI 74026026Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- JOURNEY 74026029Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- JOURNEY 74026035Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- JOURNEY 74026158Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- JOURNEY 74026170Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- JOURNEY 74026728Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- JOURNEY 74013784Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- JOURNEY 74016404Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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