Smith & Nephew knee implant recall: wrong size in packaging
Smith & Nephew recalled 8 knee implants from a specific lot after finding packages labeled as SIZE 5N contained SIZE 4N implants instead. Patients who received these implants should contact their surgeon immediately.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is a wrong-size implant that could affect knee joint fit and function, but no harm has been reported to date, falling under 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Smith & Nephew Inc. has recalled 8 knee implant components from lot 23EM09878 due to incorrect sizing in packaging. The recalled units are LEGION OXINUM POSTERIOR STABILIZED NONPOROUS COMPONENTS, SIZE 5N, LEFT, NARROW (UDI/DI: 00885556234006).
According to a complaint, one package contained a SIZE 4N implant instead of the SIZE 5N implant as labeled. This size mismatch could cause improper fit of the knee implant if implanted unknowingly.
The implants were distributed to facilities in Ohio, Connecticut, Texas, North Carolina, California, Nebraska, and Nevada. Patients who may have received implants from this lot should immediately contact Smith & Nephew or their surgeon to verify that the correct size component was implanted.
The recalled product
- Product
- smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
- Manufacturer
- Smith & Nephew Inc
- Hazard
- implant-size-mismatch
- product-mispackaging
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 (2)
- UDI/DI: 00885556234006
- Lot Number: 23EM09878
Distribution
Distributed in 7 states:
- CA
- CT
- NC
- NE
- NV
- OH
- TX
Related recalls
Same category
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27