Smith&nephew Leigon Oxinium Constrained Nonporous recall
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL…
Why was Smith&nephew Leigon Oxinium Constrained Nonporous recalled?
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 03596010543837, Batch Number 23LM03388
- Product
- smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL…
- Recalling firm
- Smith & Nephew Inc
- Quantity
- 2 units
- Distribution
- US Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,.
- Recall date
- November 6, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)