Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 are cemented and ceme — recall Z-1479-2020

U.S. FDA — Device Enforcement · United States · 2020-01-21 · Class II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1479-2020
Date of alert
2020-01-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Aesculap Implant Systems LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
52533610
Reported risk: Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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