# FDA recall Z-1480-2020

> **Aesculap Implant Systems LLC** · Class II · device recall initiated 2020-01-21.

## 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 implant parts there are cemented and cement-free versions as well as versions with zirconium nitride multi layer.

## Reason for recall

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

## Distribution

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.

## Key facts

- **Recall number:** Z-1480-2020
- **Recalling firm:** Aesculap Implant Systems LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-21
- **Report date:** 2020-03-25
- **Termination date:** 2021-09-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1480-2020

## Citation

> AI Analytics. FDA recall Z-1480-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1480-2020. Source: US FDA. Licensed CC0.

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