Z-1168-2014 Class II Terminated
FDA device recall Z-1168-2014 was initiated by Biomet 3I, LLC on Jul 22, 2013 and is designated Class II. Reason for recall: During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required. The recall status is terminated (terminated Apr 21, 2015). Affected quantity: 170.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 19, 2014
- Initiation Date
- Jul 22, 2013
- Termination Date
- Apr 21, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 170
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, including Hawaii and Puerto Rico and the countries of : Argentina, Austria, Canada, China, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Hungary, Israel, Japan, Korea, Mexico, Poland, Portugal, Paraguay, Sweden, Singapore, Taiwan, and Uruguay.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1168-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026