Aesculap Columbus Knee Implant Components Recalled for LDPE Particles
Aesculap is recalling Columbus R/PS Tibia Plateau knee implant components because low-density polyethylene particles may be present on the surface upon opening.
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 involves a high-risk medical device (knee implant) with a potential contamination hazard (LDPE particles), but the source text does not report any illnesses, injuries, or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Aesculap Implant Systems LLC is recalling Columbus R/PS TIB.PLATEAU Cemented knee implant components, including various sizes and model numbers NN058K through NN079K. The recall involves 24,010 units that were distributed worldwide and across numerous U.S. states.
The recall was initiated because low-density polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. The source text does not specify reported illnesses, injuries, or deaths associated with this issue.
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 R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K NN073K NN074K NN075K NN076K NN077K NN078K NN079K Product Usage:Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these…
- Manufacturer
- Aesculap Implant Systems LLC
- Category
- Medical Device — Knee Implant
- Affected units
- 24,010
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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