Z-1481-2020 Class II Terminated
FDA device recall Z-1481-2020 was initiated by Aesculap Implant Systems LLC on January 21, 2020 and is designated Class II. Reason for recall: Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. The recall status is terminated (terminated September 22, 2021).
Recall Details
- Product Type
- Devices
- Report Date
- March 25, 2020
- Initiation Date
- January 21, 2020
- Termination Date
- September 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Reason for Recall
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.