Z-0564-2016 Class II Terminated
FDA device recall Z-0564-2016 was initiated by Biomet 3I, LLC on Nov 16, 2015 and is designated Class II. Reason for recall: Images contained within radiographic transparency ART 1036 are undersized. The recall status is terminated (terminated Dec 14, 2016). Affected quantity: 686.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 6, 2016
- Initiation Date
- Nov 16, 2015
- Termination Date
- Dec 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 686
Product Description
Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.
Reason for Recall
Images contained within radiographic transparency ART 1036 are undersized.
Distribution Pattern
Worldwide Distribution - US Distribution including Puerto Rico., and to the states of : CA, CO, FL, IL, MA, MI, MO, NY, OH, SC, TX, VA, WI, WV and Hawaii., and to the countries of : Australia, Germany, France, Greece, Northern Mariana Islands, Taiwan and Uruguay.
Code Information
Model Number: ART 1036, Rev. C 03/13; Purchase Order # 184427.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0564-2016
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026