Aesculap Recalls Columbus Knee Implant Components Due to LDPE Particles
Aesculap Implant Systems LLC is recalling Columbus knee implant components because low-density polyethylene particles may be present on the surface when the packaging is opened.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 and involves a risk-of-harm product (medical implant) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Aesculap Implant Systems LLC is recalling specific Columbus knee implant components, specifically the Tibia-Plateaus, due to the potential presence of Low Density Polyethylene (LDPE) particles on the implant surface. The affected products are identified by model numbers NN469K through NN479K and are distributed worldwide, including in the United States and numerous international markets.
The recall is limited to products with the old packaging configuration. The new packaging configuration begins with Lot 52533610. These implant parts are used in knee endoprosthetics and are available in cemented and cement-free versions, as well as versions with zirconium nitride multi-layer coatings.
The FDA has classified this recall as Class II. The hazard involves the potential presence of LDPE particles upon the opening of the inner packaging. No specific instructions for consumers are provided in the source text, but the recall is managed by the recalling firm, Aesculap Implant Systems LLC.
The recalled product
- Product
- COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K NN473K NN474K NN475K NN476K NN477K NN478K NN479K Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these…
- Manufacturer
- Aesculap Implant Systems LLC
- Hazard
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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