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GoDirect Screw-Retaining Top recallZ-0961-2017 · Implant Direct Sybron Manufacturing, LLC · initiated Nov 28, 2016

Class II Terminated All recalls posted in January 2017

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Implant Direct Sybron Manufacturing, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Labeling mix-ups

What the company is doing

On 11/28/16 customers were called and instructed to return the product.

Recall details

Recall number
Z-0961-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 28, 2016
Posted by the FDA
Jan 9, 2017
Recalling firm
Implant Direct Sybron Manufacturing, LLC
Quantity
14
Product code
DZE
FDA submissions
K090234
Distribution
U.S. distribution to the following; WA. Foreign distribution to the following; Netherlands.

Product description

GoDirect Screw-Retaining Top Part Numbers: 4500-61

Code information (models, lots, serial numbers)

Lot #75808

Other devices under the same FDA submission

123 devices cleared under K090234 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page