Z-2144-2014Class II

Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component

Name: Z-2144-2014 Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component
Creator: Zimmer, Inc.
Published: 2014-07-17
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-07-17 / Terminated / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component on 2014-07-17. FDA classified it as Class II and gives the reason as "Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm."". 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-2144-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-17
Posted: 2014-08-02
Terminated: 2015-02-06
Recalling firm: Zimmer GmbH
Product: Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm."
Root cause tag: manufacturing process
FDA root cause: Process design
Action: A recall letter dated 7/22/14 was sent to all customers who purchased the Tapered Screw-Vent Implant to inform them of the recall by Zimmer Dental. The letter informs the customers of the problems identified, risks involved, and the actions to be taken. Customers with questions are instructed to contact Zimmer Dental Customer Service at (800) 854-7019, 7-5pm, Mon-Fri. Customers are instructed to complete the customer response form and e-mail a copy to [email protected] or fax to (574) 372-4265.
Quantity in commerce: 291 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Holland, Italy, and Japan.
Product codes and lots: Lot No. 62552804

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2144-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2144-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-02

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)