smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
This recall is currently active, issued September 20, 2023. It was issued by Smith & Nephew Inc.
- Company
- Smith & Nephew Inc
- Recall Initiated
- August 31, 2023
- Posted
- September 20, 2023
- Recall Number
- Z-2621-2023
- Quantity
- 8 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
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.
Distribution
OH, CT, TX, NC, CA, NE, NV
Lot / Code Info
UDI/DI: 00885556234006, Lot Number: 23EM09878
Root Cause
Labeling Change Control
Action Taken
Smith & Nephew issued an Urgent Medical Device3 Recall Notice to its consignees on 08/31/2023 via letter and email. The notice explained the problem and potential risk and requested the consignee quarantine the affected product. Distributors were directed to notify their customers. Firm is seeking return of the affected product.