Z-1189-2018Class II

Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10

Name: Z-1189-2018 Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10
Creator: Zimmer Dental Inc
Published: 2017-11-29
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2017-11-29 / Terminated / root cause: packaging

FDA source

Zimmer Dental Inc began a recall of Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10 on 2017-11-29. FDA classified it as Class II and gives the reason as "Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1189-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-29
Posted: 2018-03-05
Terminated: 2019-02-08
Recalling firm: ZimVie US Corp LLC
Product: Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On 11/29/2017, customers were notified via letter. Instructions for distributors include to ensure that affected team members are aware of the recall, immediately locate and quarantine affected devices in inventory, notify consignees if product was distributed, make arrangements to immediately return affected devices, and complete and return the Attachment 1 - Inventory Return Certification Form. Instructions for clinicians include to review the recall notice, examine inventory for affected devices, complete and return the Attachment 2 - Certificate of Acknowledgement, and return all affected devices.
Quantity in commerce: 995 distribution events total
Distribution: Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
Product codes and lots: Lot No. 63621027, UDI #(01)00889024019928 (17)220331 (10)63619437.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1189-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1189-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-26
Z-1190-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-26

Product code DZE

K101977Class IITapered Screw-Vent T ImplantZimmer Dental, Inc. / cleared 2010-09-14

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)