Recall Z-0776-2016 ยท DZE Implant, Endosseous, Root-Form
Zimmer Dental Inc
IMPLANT,TM, MTX 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMMB11 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.
| Date | Feb 9, 2016 (initiated Jan 6, 2016) |
| Status | Terminated |
| Reason | 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 | 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 B |
| Quantity | 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, Pol |
| 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 |