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Recall Observatory FDA recall evidence

Device 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: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there are cemented and cement-free versions as well as versions with zirconium nitride multi layer.

Z-1482-2020

January 21, 2020

Class II

Product summary

Firm
Aesculap Implant Systems LLC
Event
Event 84865
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1482-2020

Official wording

Reason: Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.

Code information: All product with old packaging configuration. New packaging configuration begins with Lot 52533610.

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, OH, OK, OR, PA, TN, TX, UT, WA and countries of Saudi Arabia, Utd. Arab Emir., Argentina, Austria, Australia, Bosnia-Herz., Bulgaria, Brazil, Switzerland, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Germany, Algeria, Ecuador, Estonia, Spain, United Kingdom, Georgia, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Libya, Moldavia, Mexico, Malaysia, Nigeria, Netherlands, Poland, Portugal, Paraguay, Russian Fed., Singapore, El Salvador, Thailand, Turkey, Ukraine, South Africa.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.