Z-0153-2015Class II

Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed...

Name: Z-0153-2015 Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed...
Creator: Zimmer Dental Inc
Published: 2014-10-01
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2014-10-01 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Dental Inc began a recall of Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for... on 2014-10-01. FDA classified it as Class II and gives the reason as "Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial". 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-0153-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-01
Posted: 2014-10-30
Terminated: 2015-04-28
Recalling firm: ZimVie US Corp LLC
Product: Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Customer Notification letters dated 10/6/14 were sent to all customers who purchased the Tapered Screw Vent Implant and the Spline Twist Implant because the incorrect diameter size was printed on the inner vial. The letters informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the attached Business Reply Form and fax it to (574) 372-4265 or email to [email protected]. Customers with questions are instructed to contact Zimmer Dental Customer Service at (800) 854-7019 from 7am-5pm, Monday-Friday.
Quantity in commerce: 1,044 units
Distribution: Worldwide Distribution-US (nationwide) and the countries of Poland, Canada, Belgium, Italy, France, Israel, Morocco, Spain, Costa Rica, and Japan.
Product codes and lots: Lot No. 61792330

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0153-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0153-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-30
Z-0154-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-30

Product code DZE

K093164Class II3.25 Spline Twist Implant, Ha CoatedZimmer Dental, Inc. / cleared 2009-12-15

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)