PlainRecalls
FDA Devices Moderate Class II Terminated

GoDirect Screw-Retaining Top Part Numbers: 4500-61

Reported: January 18, 2017 Initiated: November 28, 2016 #Z-0961-2017

Product Description

GoDirect Screw-Retaining Top Part Numbers: 4500-61

Reason for Recall

Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.

Details

Units Affected
14
Distribution
U.S. distribution to the following; WA. Foreign distribution to the following; Netherlands.
Location
Westlake Village, CA

Frequently Asked Questions

What product was recalled?
GoDirect Screw-Retaining Top Part Numbers: 4500-61. Recalled by Implant Direct Sybron Manufacturing, LLC. Units affected: 14.
Why was this product recalled?
Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 18, 2017. Severity: Moderate. Recall number: Z-0961-2017.