The Recall Desk
HighFDA (Devices)·Z-1951-2021·Announced 2021-06-30

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.

What this means for you

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.
Category
Medical Device — Orthopedic Implant
Hazard
  • manufacturing-defect
  • surface-damage

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

Distributed nationwide across the United States.

Related recalls

Same category