Z-0284-2018Class II

Tapered Screw-Vent MTX Model TSVTB11

Name: Z-0284-2018 Tapered Screw-Vent MTX Model TSVTB11
Creator: Zimmer Dental Inc
Published: 2017-11-20
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2017-11-20 / Terminated / root cause: manufacturing process

FDA source

Zimmer Dental Inc began a recall of Tapered Screw-Vent MTX Model TSVTB11 on 2017-11-20. FDA classified it as Class II and gives the reason as "Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition". 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-0284-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-20
Posted: 2017-12-22
Terminated: 2024-02-28
Recalling firm: ZimVie US Corp LLC
Product: Tapered Screw-Vent MTX Model TSVTB11
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Recall notification letters will be sent to distributors and clinicians on or about the last week of November 2017. International distributors will be notified via courier or email. Clinicians will be instructed to; 1. Follow any specified patient monitoring instructions, 2. Return Attachment 1 (Acknowledgment of Responsibility) to Zimmer Biomet, 3. Review their inventory and returning any affected product.
Quantity in commerce: 500 units
Distribution: US, Canada, France, Italy, Spain, Germany
Product codes and lots: lot,#63519794; UDI: (01)00889024019935 (17)211130 (10)63519794

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0284-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0284-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-21

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)