Aesculap Recalls Knee Implant Components 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 upon opening.
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 medical device where foreign particles (LDPE) may be present on the implant surface. This represents a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Aesculap Implant Systems LLC is recalling AS COLUMBUS CR/PS TIB.PLAT.CEMENTED knee implant components, including various sizes and model numbers NN058Z through NN079Z and NN470Z through NN479Z. The recall affects 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 tibial plateaus 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, including states such as AL, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, OH, OK, OR, PA, TN, TX, UT, and WA. 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 return or replacement of these specific implant components.
The recalled product
- Product
- AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z NN075Z NN076Z NN077Z NN078Z NN079Z NN470Z NN471Z NN472Z NN473Z NN474Z NN475Z NN476Z NN477Z NN478Z NN479Z Product Usage: Tibia-Pl
- 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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