LEGION Knee Prosthesis Component Recalled for Manufacturing Surface Damage
Smith & Nephew is recalling 5 units of a knee prosthesis component due to surface damage from a manufacturing error. The affected lot was distributed in specific U.S. states.
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 of an implanted device with no reported illnesses or injuries. The manufacturing-caused surface damage is a real defect, but injury has not been reported. Per the rubric, a risk-of-harm product where injury has not yet been reported scores 3 (High).
Plain-English summary
Smith & Nephew, Inc. is recalling the LEGION Posterior Stabilized OXINIUM Femoral Component (Reference 71421216, Size 6, Left, Lot 20HM17607), a knee prosthesis component used in knee replacement surgery. The recall affects 5 units distributed in Florida, Nebraska, New York, and Texas.
A manufacturing process error resulted in surface damage to these components during product handling. Smith & Nephew identified the issue and initiated this recall.
Patients who received this component should contact their healthcare provider or surgeon to discuss the recall and their specific situation. Healthcare providers should verify lot numbers in their inventory and follow Smith & Nephew's recall instructions.
The recalled product
- Product
- LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 5
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 (1)
- Lot 20HM17607
Distribution
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