The Recall Desk
HighFDA (Devices)·Z-0872-2024·Announced 2024-02-07

Knee replacement implant recalled for material oxidation risk

Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee replacement components due to potential oxidation of the UHMWPE material in units manufactured with raw material over 5 years of age.

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: This is a risk-of-harm medical device (orthopedic implant) where injury has not yet been reported. The FDA Class II recall addresses theoretical material oxidation in UHMWPE components without reported illnesses or injuries.

Plain-English summary

Howmedica Osteonics Corp. is recalling 70 units of the SCORPIO RECESSED PATELLA knee replacement (Part Number 3044-0032) distributed nationwide in the United States and internationally.

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can impact its material properties.

Patients with implanted devices from the affected lot numbers (6LR4, R14V, N882) should consult with their orthopedic surgeon or healthcare provider regarding potential risks and whether any action is needed.

The recalled product

Product
SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032
Manufacturer
Howmedica Osteonics Corp.
Category
Medical Device — Joint Replacement / Orthopedic Implant
Hazard
  • oxidation
  • material-degradation

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 (3)

  • GTIN: 07613327033823 Lot Numbers: 6LR4
  • R14V
  • N882

Distribution

Distributed nationwide across the United States.

Related recalls

Same category