Agency classClass IIOur severity:High FDA (Devices)·Z-1099-2022·Announced 2022-05-25

Smith & Nephew knee implants recalled for labeling error

Smith & Nephew is recalling knee implants shipped in incorrect packaging—a JOURNEY II femoral implant was boxed as a LEGION NARROW PS implant. The labeling error could result in the wrong implant being used during surgery.

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 medical device recall involving a risk-of-harm product—an incorrect orthopedic implant could potentially be used in surgery if the labeling error is not detected. Although no injuries or illnesses have been reported, the error creates significant clinical risk.

Plain-English summary

Smith & Nephew Inc is recalling the LEGION NARROW PS OXIN (Size 6N, right) and JOURNEY II BCS FEMORAL OXIN (Size 5, left)—orthopedic implants used in knee replacement surgery. These products are subject to FDA Class II recall.

The recall was initiated after discovery that a JOURNEY II BCS Femoral OXIN (LT, Size 5) was shipped in packaging labeled as a LEGION NARROW PS OXIN (6N, RT). This mislabeling could allow the wrong implant to be used during surgery if undetected before implantation.

The affected products were distributed worldwide, with US distribution to Connecticut, North Carolina, Colorado, South Carolina, Virginia, Florida, Illinois, and California, as well as Japan. Specific lot numbers and product codes are provided to support identification.

Patients and healthcare providers should verify product information before use. Those who have received these implants should contact Smith & Nephew or their healthcare provider to confirm the correct product was implanted.

The recalled product

Product: LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
Manufacturer: Smith & Nephew Inc
Category: Medical Device — Orthopedic implant
Hazard: mis-labeling
product-mismatch
Affected units: 16

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)

LEGION NARROW PS OXIN SZ 6N RT: Model Number: 71421276
Lot: 21JM17389
Lot: 21JM18618
UDI: (01)00885556170410(17)310926(10)21JM18618

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Same manufacturer · Smith & Nephew Inc

See all →

High
TRIGEN proximal humeral nails are missing their distal holes
FDA (Devices) · 2026-06-24
Moderate
Bone fixation screws recalled over a labeling error on one lot
FDA (Devices) · 2025-12-24
Moderate
Smith & Nephew Lag/Compression Screw Kit Undersized Socket Defect
FDA (Devices) · 2025-05-28
High
BIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach
FDA (Devices) · 2024-12-11
High
Smith & Nephew Bipolar Hip Implant Component Recalled for Oversized Retainer Ring
FDA (Devices) · 2024-11-13

Same hazard · mis labeling