Z-2050-2014Class II

Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006

Name: Z-2050-2014 Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
Creator: Zimmer, Inc.
Published: 2014-06-25
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-06-25 / Terminated

FDA source

Zimmer, Inc. began a recall of Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006 on 2014-06-25. FDA classified it as Class II and gives the reason as "Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2050-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-25
Posted: 2014-07-14
Terminated: 2014-10-30
Recalling firm: Zimmer GmbH
Product: Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial.
FDA root cause: Under Investigation by firm
Action: Recall notification letters sent to customers on 06/25/14. The recall letter, titled "URGENT DEVICE RECALL NOTICE", delivered to customers via a courier, with instructions for returning any unused affected product. The recall letter was accompanied with a response form and provided the following information to customers: product information with codes, reason for recall, risks, responsibilities, MedWatch Reporting and contacting information.
Quantity in commerce: 129 units
Distribution: Nationwide Distribution.
Product codes and lots: Catalog Number TSVT6B13, Lot Number 62284006. 5-year expiration. January 2018.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2050-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2050-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-14

Product code DZE

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)