# FDA recall Z-1481-2020

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

## Product

AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components,  various sizes, model nos.  NN058Z  NN070Z  NN071Z  NN072Z  NN073Z  NN074Z  NN075Z  NN076Z  NN077Z  NN078Z  NN079Z  NN470Z  NN471Z  NN472Z  NN473Z  NN474Z  NN475Z  NN476Z  NN477Z  NN478Z  NN479Z  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-1481-2020
- **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-1481-2020

## Citation

> AI Analytics. FDA recall Z-1481-2020. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1481-2020. Source: US FDA. Licensed CC0.

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