The Recall Desk
HighFDA (Devices)·Z-0926-2024·Announced 2024-02-07

Tibial Knee Replacement Implants Recalled Due to Material Oxidation

Howmedica Osteonics is recalling tibial bearing inserts used in knee replacements manufactured from UHMWPE raw material over 5 years old. The material may develop elevated oxidation levels that could impact its structural properties.

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 an FDA Class II recall of an orthopedic implant component where UHMWPE material may undergo oxidation affecting its structural properties. No illnesses or injuries have been reported, and the hazard is theoretical based on material age. Per FDA severity criteria, risk-of-harm products where injury has not yet been reported are classified as High severity.

Plain-English summary

Howmedica Osteonics Corp. is recalling TIBIAL BEARING INSERT SERIES P-S I ASSY (Product Number 7291-0324), components used in knee replacement surgery, manufactured using UHMWPE (ultra-high-molecular-weight polyethylene) raw material that is more than 5 years old.

UHMWPE raw material older than 5 years has the potential to develop elevated levels of oxidation. When oxidation occurs within UHMWPE, it can degrade the material's structural properties, which in an orthopedic implant could affect its performance and durability.

The recalled product was distributed nationwide and internationally, including to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, the Netherlands, and additionally to Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain as of January 25, 2024. The affected lot number is 59065701.

Consumers who have received this implant should contact their healthcare provider or Howmedica Osteonics Corp. for guidance. No injuries or illnesses related to this issue have been reported to date.

The recalled product

Product
TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324
Manufacturer
Howmedica Osteonics Corp.
Category
Medical Device — Orthopedic Implant / Knee Replacement
Hazard
  • material-oxidation
  • material-degradation
  • structural-integrity-risk

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)

  • GTIN: 04546540117144 Lot Numbers: 59065701

Distribution

Distributed nationwide across the United States.

Related recalls

Same category