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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 12
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
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