Z-2452-2016 Class II Terminated
FDA device recall Z-2452-2016 was initiated by Biomet 3I, LLC on Nov 25, 2015 and is designated Class II. Reason for recall: Pouches may not have been sealed during packing. The recall status is terminated (terminated Jul 26, 2019). Affected quantity: 1,648,273 devices (all products subject to this recall).
Recall Details
- Product Type
- Devices
- Report Date
- Aug 24, 2016
- Initiation Date
- Nov 25, 2015
- Termination Date
- Jul 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,648,273 devices (all products subject to this recall)
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.
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-2452-2016
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026