Z-1511-2012

Zimmer Dental Trabecular Metal, TMT4B11 IMP TM 4.1MM MTX FULL,11.5MM; Rx, Sterile R, www.zimmerdental.com...

Name: Z-1511-2012 Zimmer Dental Trabecular Metal, TMT4B11 IMP TM 4.1MM MTX FULL,11.5MM; Rx, Sterile R, www.zimmerdental.com...
Creator: Zimmer Inc.
Published: 2012-03-22
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-03-22 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Inc. began a recall of Zimmer Dental Trabecular Metal, TMT4B11 IMP TM 4.1MM MTX FULL,11.5MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA The... on 2012-03-22. The reason FDA records is "This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implant assembly during...". 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-1511-2012
Status: Terminated
Initiated: 2012-03-22
Posted: 2012-05-10
Terminated: 2012-12-03
Recalling firm: Zimmer GmbH
Product: Zimmer Dental Trabecular Metal, TMT4B11 IMP TM 4.1MM MTX FULL,11.5MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, Page 4 of 6 especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implant assembly during surgery on a patient with a dense (Type D1), thick, inferior border. The recall correction includes adding precautions to the Instructions for Use regarding the placement of a 4.1mm
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Zimmer sent an Urgent Medical Device Correction notification letter dated April 24, 2012, with an attached Technical Bulletin listing precautions present in the new Informaiton for Use sent to distributors and customers via E-mail and FED EX. Notifications identified the issue and risks found with the device listing responsibilties, precautions, and procedural precautions. Notifications contained directions to forward information to any sub accounts and clinicians. Zimmer had telephone follow-up with each distributor and customer to assure information was received and is understood. Questions should be directed to Technical Service (800)8511-7019 orCustomer Service(760) 929-1300 or Regulatory Affairs at 1-800-854-7019 . For questions regarding this recall call 574-372-4807.
Quantity in commerce: 202
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
Product codes and lots: Catalog # TMT4B11: Lot 61926103, 61960168, 61967139, 61978064, 61989032

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)