Aesculap Recalls Columbus Knee Implant Components Due to LDPE Particles
Aesculap Implant Systems LLC is recalling Columbus CR/PS Tibial Plateau knee implant components because low-density polyethylene particles may be present on the surface.
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: The recall involves a high-risk medical device where a foreign material hazard (LDPE particles) is present, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Aesculap Implant Systems LLC is recalling Columbus CR/PS Tibial Plateau knee implant components, including various sizes and model numbers NN081K through NN089K. These components are part of knee endoprosthetics and are available in cemented, cement-free, and zirconium nitride multi-layer versions.
The recall is being conducted because low-density polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. The affected products are those with the old packaging configuration; the new packaging configuration begins with Lot 52533610.
The products were distributed worldwide and nationwide in the United States, including in states such as Alabama, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, and Washington. International distribution included countries such as Saudi Arabia, the United Arab Emirates, Argentina, Austria, Australia, and many others. Healthcare providers and patients should contact Aesculap Implant Systems LLC for further instructions regarding the recall.
The recalled product
- Product
- COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos. NN081K NN082K NN083K NN084K NN085K NN086K NN087K NN088K NN089K Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there a
- Manufacturer
- Aesculap Implant Systems LLC
Distribution
Part of a larger recall action
This product is one of 5 recalled by Aesculap Implant Systems LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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