Implant Direct Sybron Manufacturing, LLC: Medical Device Recall in 2017 - (Recall #: Z-0961-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

GoDirect Screw-Retaining Top Part Numbers: 4500-61

Product Classification:

Class II

Date Initiated: November 28, 2016

Date Posted: January 18, 2017

Recall Number: Z-0961-2017

Event ID: 75838

Reason for Recall:

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

Status: Terminated

Product Quantity: 14

Code Information:

Lot #75808

Distribution Pattern:

U.S. distribution to the following; WA. Foreign distribution to the following; Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated