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.
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: 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
- Affected units
- 8
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
Related recalls
Same manufacturer · Smith & Nephew Inc
See all →- HighTRIGEN proximal humeral nails are missing their distal holes
FDA (Devices) · 2026-06-24
- ModerateBone fixation screws recalled over a labeling error on one lot
FDA (Devices) · 2025-12-24
- ModerateSmith & Nephew Lag/Compression Screw Kit Undersized Socket Defect
FDA (Devices) · 2025-05-28
- HighBIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach
FDA (Devices) · 2024-12-11
- HighSmith & Nephew Bipolar Hip Implant Component Recalled for Oversized Retainer Ring
FDA (Devices) · 2024-11-13
Same hazard · implant size mismatch
See all →- HighSmith & Nephew Knee Prosthesis Recalled for Wrong Size Shipped
FDA (Devices) · 2024-11-06
- HighHip Prosthesis Implants Recalled for Size Mismatch Between Label and Device
FDA (Devices) · 2023-09-13
- HighG7 Acetabular Liner Recalled for Size and Label Discrepancy
FDA (Devices) · 2023-03-29
- HighEMPOWR VVC Knee Tibial Insert Recalled for Reversed Box Labeling
FDA (Devices) · 2023-03-08
- HighExeter V40 Cemented Hip Stem Recalled for Potential Label Mix-Up
FDA (Devices) · 2022-02-23
Similar recalls
- HighSmith & Nephew Knee Prosthesis Component Recalled for Incorrect Labeling
FDA (Devices) · 2024-11-06
- HighSmith & Nephew Knee Prosthesis Recalled for Wrong Size Shipped
FDA (Devices) · 2024-11-06
- HighKnee Prosthesis Implant Recall: Wrong Size Component Shipped
FDA (Devices) · 2024-11-06
- HighSmith & Nephew Knee Prosthesis Component Packaging Error: Wrong Implant Shipped
FDA (Devices) · 2024-11-06
- HighSmith & Nephew knee implants recalled for labeling error
FDA (Devices) · 2022-05-25
- HighLEGION Knee Prosthesis Component Recalled for Manufacturing Surface Damage
FDA (Devices) · 2021-06-30