Z-0961-2017Class II

GoDirect Screw-Retaining Top Part Numbers: 4500-61

Name: Z-0961-2017 GoDirect Screw-Retaining Top Part Numbers: 4500-61
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2016-11-28
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2016-11-28 / Terminated / root cause: labeling and UDI

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of GoDirect Screw-Retaining Top Part Numbers: 4500-61 on 2016-11-28. FDA classified it as Class II and gives the reason as "Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0961-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-28
Posted: 2017-01-09
Terminated: 2017-02-16
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: GoDirect Screw-Retaining Top Part Numbers: 4500-61
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On 11/28/16 customers were called and instructed to return the product.
Quantity in commerce: 14
Distribution: U.S. distribution to the following; WA. Foreign distribution to the following; Netherlands.
Product codes and lots: Lot #75808

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0961-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0961-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-09

Product code DZE

K090234Class IISpectra System Dental Implants 2008Implant Direct, LLC / cleared 2009-05-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)