Smith & Nephew Knee Implant Component Mispack: Wrong Size Distributed
Smith & Nephew is recalling 12 JOURNEY II UNI Tibia Insert components due to a manufacturing mispack. Some boxes incorrectly contain a different size component.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II mispack of a surgical implant component that poses a risk of surgical complications if the wrong size component is implanted. No illnesses or injuries have been reported.
Plain-English summary
Smith & Nephew is recalling 12 units of JOURNEY II UNI XLPE Tibia Insert Medial Size 7-8 8MM due to a manufacturing mispack. During production, some boxes were incorrectly filled with JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the ordered size.
The affected units were distributed nationwide to hospitals and surgical centers in Illinois, Maryland, Michigan, Mississippi, New York, Ohio, Texas, Virginia, and Washington. If the wrong-size component is used during surgery, it could result in surgical complications or the need for revision surgery.
The FDA has classified this as a Class II recall. Smith & Nephew has notified customers and is working to retrieve affected units. Hospitals and surgical centers that received these units should verify the product size against their purchase order before use and contact Smith & Nephew with any questions.
The recalled product
- Product
- JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- mispack
- wrong-size-implant
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalog Number: 74026178
- UDI/DI: 00885556677209
- Batch Number: 22CAP0038R
- Lot Number: 22CAP0038R
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighPhilips Avalon Fetal Monitor FM 30 Speaker Connector Assembly
FDA (Devices) · 2026-07-01
- SevereDexcom G7 Continuous Glucose Monitoring System sensors recalled
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01