Z-2125-2017 Class II Terminated
FDA device recall Z-2125-2017 was initiated by Implant Direct Sybron Manufacturing, LLC on May 2, 2017 and is designated Class II. Reason for recall: Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification. The recall status is terminated (terminated January 8, 2018). Affected quantity: 151 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 31, 2017
- Initiation Date
- May 2, 2017
- Termination Date
- January 8, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 151 units
Product Description
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
Reason for Recall
Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.
Distribution Pattern
Worldwide Distribution - Nationwide Distribution and to the countries of : European Union (HU, GB, DE, DK, IT, HR, FR), and Japan
Code Information
89103, 83493, 78986