Recall Z-0957-2017 ยท NDP Accessories, Implant, Dental, Endosseous
Straumann Manufacturing, Inc.
Straumann Drill 1, short, 2.2mm, l 33.0mm, SS-Non sterile. Dental implant accessory Article Number: 044.210 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlu
| Date | Nov 23, 2016 |
| Status | Terminated |
| Reason | Drills cannot be inserted into handpiece due to tolerance specification not met |
| Root cause | Under Investigation by firm |
| Action | Straumann sent an Urgent Field Safety Notice to all affected customers via UPS on November 23, 2016 for next day delivery. Customers were requested to check inventory for the listed article and lot numbers and return all unused, packaged parts. Replacement drills will be sent upon receipt. Complete the Confirmation Form and fax the form to the number listed on the form. For questions regarding this recall call 800-448-8168. |
| Quantity | 165 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.