—#108230

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.

FDA product code: DZE — Implant, Endosseous, Root-Form
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K112160
Affected lot / code info: Catalog # TMT4B11: Lot 61926103, 61960168, 61967139, 61978064, 61989032

Why it was recalled

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 (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA

Timeline

Recall initiated: 2012-03-22
Posted by FDA: 2012-05-10
Terminated: 2012-12-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108230. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.