smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARRO...
FDA Recall #Z-2621-2023 — Class II — August 31, 2023
Product Description
smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
Reason for Recall
The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.
Recalling Firm
Smith & Nephew Inc — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
8 units
Distribution
OH, CT, TX, NC, CA, NE, NV
Code Information
UDI/DI: 00885556234006, Lot Number: 23EM09878
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated