Keystone Dental PrimaConnex Straight Implant TC, RD… recallZ-0299-2017 · Keystone Dental Inc · initiated Sep 15, 2016
Class II Terminated All recalls posted in October 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Keystone Dental Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
FDA root cause category: Packaging process control
What the company is doing
Keystone Dental initially called all customers on September 15, 2016. Forms were completed to document these calls. In addition a letter has been sent via Federal Express/or hand delivered on September 19, 2016, to all distributors and customers. Customers with questions were instructed to contact Customer Relations. For questions regarding this recall call 781-328-3390.
Recall details
- Recall number
- Z-0299-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 15, 2016
- Posted by the FDA
- Oct 21, 2016
- Recalling firm
- Keystone Dental Inc
- Quantity
- 55 units
- Product code
- DZE
- FDA submissions
- K051614
- Distribution
- Worldwide distribution - US (Nationwide Distribution to CA, CO, IL, MA, MN, ND, NY, NV, PA, and VA.) and Italy
Product description
Keystone Dental PrimaConnex Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained, screw retained, or overdenture restorations and terminal or inter-mediate abutment support for fixed bridgework
Code information (models, lots, serial numbers)
Lot # 27714
Other devices under the same FDA submission
53 devices cleared under K051614 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Prima Implant System 15617KKeystone Dental, Inc. · IMPLANT, ENDOSSEOUS, ROOT-FORM379 reports
- Prima Implant System 15618KKeystone Dental, Inc. · IMPLANT, ENDOSSEOUS, ROOT-FORM328 reports
- Prima Implant System 15613KKeystone Dental, Inc. · IMPLANT, ENDOSSEOUS, ROOT-FORM287 reports
- Prima Implant System 15621KKeystone Dental, Inc. · IMPLANT, ENDOSSEOUS, ROOT-FORM270 reports
- Prima Implant System 15619KKeystone Dental, Inc. · IMPLANT, ENDOSSEOUS, ROOT-FORM248 reports
- Prima Implant System 15614KKeystone Dental, Inc. · IMPLANT, ENDOSSEOUS, ROOT-FORM216 reports
- Prima Implant System 15622KKeystone Dental, Inc. · IMPLANT, ENDOSSEOUS, ROOT-FORM181 reports
- Prima 15736KKeystone Dental, Inc. · IMPLANT, ENDOSSEOUS, ROOT-FORM151 reports
- Prima Implant System 15615KKeystone Dental, Inc. · IMPLANT, ENDOSSEOUS, ROOT-FORM145 reports
- Prima 15741KKeystone Dental, Inc. · IMPLANT, ENDOSSEOUS, ROOT-FORM111 reports
- Prima Implant System 15634KKeystone Dental, Inc. · IMPLANT, ENDOSSEOUS, ROOT-FORM90 reports
- Prima 15737KKeystone Dental, Inc. · IMPLANT, ENDOSSEOUS, ROOT-FORM87 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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