Z-2125-2017Class II

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

Name: Z-2125-2017 Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2017-05-02
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2017-05-02 / Terminated / root cause: manufacturing process

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD on 2017-05-02. FDA classified it as Class II and gives the reason as "Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2125-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-02
Posted: 2017-05-22
Terminated: 2018-01-08
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
Product code: DZE Implant, Endosseous, Root-Form
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Implant Direct sent an Urgent Medical Device Field Corrective recall letter dated April 2017 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are informed that the product may be out of Implant Direct specification. The abutment should have a full hex configuration from end of part to shoulder (1.6mm). When the part is in-correct there will be a noticeable diameter ring just above shoulder and a hex flat face that appears short (@ 1.1mm) not allowing full engagement to implant analog. This discrepancy may lead to the possibility of the abutment not seating properly on the implant, and if undetected may lead to micro-leakage and a possible infection to the patient. Customers are instructed to complete and return the Acknowledgement and Recall Return form within 48 hrs. Customers with any questions are instructed to contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.
Quantity in commerce: 151 units
Distribution: Worldwide Distribution - Nationwide Distribution and to the countries of : European Union (HU, GB, DE, DK, IT, HR, FR), and Japan
Product codes and lots: 89103, 83493, 78986

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2125-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2125-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-22

Product code DZE

K061319Class IISpectra SystemImplant Direct, LLC / cleared 2006-09-29

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)