Z-0779-2016Class II

IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMT4B11

Name: Z-0779-2016 IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMT4B11
Creator: Zimmer Dental Inc
Published: 2016-01-06
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2016-01-06 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Dental Inc began a recall of IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMT4B11 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or... on 2016-01-06. FDA classified it as Class II and gives the reason as "Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections". 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-0779-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-06
Posted: 2016-02-09
Terminated: 2016-05-06
Recalling firm: ZimVie US Corp LLC
Product: IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMT4B11 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Zimmer sent an Urgent Device Correction letter dated January 6, 2016 to all affected customers.. The letter identified the affected product, problem and actions to be taken. Customers were asked to do the following; review the notice and check inventory for the affected units, ff they wish to keep the product familiarize themselves with the Technical Bulletin information, if they wish to return the affected product call Zimmer Dental Customer Service at 1-800-854-7019 to obtain a Return Authorization Number and to setup a FedEx pick-up to return the products, and complete Attachment 1, the Business Reply Form. It was requested that customers maintain a copy of the noticeand a signed copy of Attachment 1 for your records. For assistance or any other questions contact Zimmer Dental Customer Service at 1-800-854-7019. Customer Service is available 7:00am to 5:00pm (Pacific), Monday through Friday.
Quantity in commerce: 1059
Distribution: Worldwide Distribution. US Nationwide in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy
Product codes and lots: Lot # 63192990 63203112 63236810

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0779-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0772-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-08
Z-0773-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-08
Z-0774-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-08
Z-0775-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-08
Z-0776-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-08
Z-0777-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-08
Z-0778-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-08
Z-0779-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-08
Z-0780-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-08
Z-0781-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-08
Z-0782-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-08
Z-0783-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-08
Z-0784-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-08

Product code DZE

K112160Class IITapered Screw-Vent X ImplantZimmer Dental, Inc. / cleared 2011-12-14

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)