PlainRecalls
FDA Devices Moderate Class II Terminated

Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD

Reported: May 31, 2017 Initiated: May 2, 2017 #Z-2125-2017

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.

Details

Units Affected
151 units
Distribution
Worldwide Distribution - Nationwide Distribution and to the countries of : European Union (HU, GB, DE, DK, IT, HR, FR), and Japan
Location
Westlake Village, CA

Frequently Asked Questions

What product was recalled?
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD. Recalled by Implant Direct Sybron Manufacturing, LLC. Units affected: 151 units.
Why was this product recalled?
Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 31, 2017. Severity: Moderate. Recall number: Z-2125-2017.