Recall Z-0718-2018 ยท DZE Implant, Endosseous, Root-Form
Keystone Dental Inc
Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or lower jaw.
| Date | Jun 16, 2017 |
| Status | Terminated |
| Reason | An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label. |
| Root cause | Unknown/Undetermined by firm |
| Action | Consignees were initially called between June 13, 2017 and June 20, 2017. Customer Relations Fax Back forms were completed to document the phone calls. A notification letter was also sent via FedEx or hand-delivered on 6/19/17. All returned product will be scrapped. For further questions, please call (781) 328-3313. |
| Quantity | 72 |
| Distribution | USA (nationwide) Distribution to the states of : CA, CO, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NY, OH, PA, TN, TX, UT, VA, VT, WA, WI and WV; and Internationally to Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071161 | ENDOSSEOUS DENTAL IMPLANT SYSTEM Southern Implants, Inc., Nov 16, 2007 |