# FDA recall Z-1482-2020

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

## 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.

## 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-1482-2020
- **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-1482-2020

## Citation

> AI Analytics. FDA recall Z-1482-2020. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1482-2020. Source: US FDA. Licensed CC0.

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