Recall Z-1515-2012 ยท DZE Implant, Endosseous, Root-Form
Zimmer Inc.
Zimmer Dental Trabecular Metal Implant, TMM4B13, 4.1mm x13MM; 3.5 mm implant TM, MTX Rx, Sterile R, , Zimmer Dental, Carlsbad, CA 92008, USA The Trabecular Metal Dental Implant is 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
| Date | May 10, 2012 (initiated Mar 22, 2012) |
| Status | Terminated |
| Reason | 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 | 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. Questi |
| Quantity | 195 |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112160 | TAPERED SCREW-VENT X IMPLANT Zimmer Dental, Inc., Dec 14, 2011 |