Aesculap Recalls Knee Implants Due to Potential LDPE Particles
Aesculap Implant Systems LLC is recalling specific 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 is classified as FDA Class II, which indicates a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences. The presence of foreign particles on an implant surface represents a significant risk of harm, but the source text does not report specific injuries or fatalities, placing it in the High severity category rather than Severe or Critical.
Plain-English summary
Aesculap Implant Systems LLC is recalling COLUMBUS REV F TIBIA OFFSET CEMENTED knee implant components, including various sizes and model numbers NR068K through NR079Z. The recall involves products with the old packaging configuration; the new packaging configuration begins with Lot 52533610.
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. These components are part of knee endoprosthetics and are available in cemented, cement-free, and zirconium nitride multi-layer versions.
The affected products were distributed worldwide and nationwide in the United States across 26 states, including Alabama, California, and Texas. They were also distributed to numerous international countries, including Germany, Japan, and the United Kingdom. Healthcare providers and patients should contact Aesculap Implant Systems LLC for further instructions regarding the removal or replacement of these specific implant components.
The recalled product
- Product
- COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR071K NR071Z NR072K NR072Z NR073K NR073Z NR074K NR074Z NR075K NR075Z NR076K NR076Z NR077K NR077Z NR078K NR078Z NR079K NR079Z Product Usage:
- 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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