Recall Z-0281-2018 ยท NDP Accessories, Implant, Dental, Endosseous
Zimmer Dental Inc
Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STRKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental imp
| Date | Oct 11, 2017 |
| Status | Terminated |
| Reason | The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant. |
| Root cause | Employee error |
| Action | The recalling firm, Zimmer Biomet, issued "URGENT MEDICAL DEVICE RECALL" letters addressed to Clinicians dated 10/11/2017 via FedEx on 10/11/2017. Letters to the distributors dated 10/11/2017 were issued via courier or email on 10/11/2017. The letters described the product, problem and actions to be taken. The customers were instructed to review notification for awareness; review your inventory; immediately return all affected product from your facility to: Field Action PM Regulatory Compliance Zimmer Biomet 4555 Riverside Dr. Palm Beach Gardens, FL 33410 US and complete and return the Certif |
| Quantity | 166 kits |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Belgium, Bulgaria, Chile, Costa Rica, Egypt, France, Georgia, Germany, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Netherlands, Nicaragua, Poland, Portugal, Romania, Serbia, Shanghai, Spain, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.