Keystone Dental Inc. PrimaConnex Straight Implant TC, WD… recallZ-1818-2017 · Keystone Dental Inc · initiated Mar 9, 2017
Class II Terminated All recalls posted in April 2017
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
Straight PrimaConnex Implants contained Tapered PrimaConnex Implants
FDA root cause category: Labeling mix-ups
What the company is doing
Keystone Dental initiated a market removal communication by telephone to customers on 3/9/2017. Customer Relations Fax Back Forms were completed to document these calls. In addition, a letter was sent via Federal Express/or hand delivered to all distributors and customers on 3/13/2017. Product returns requested and if implanted to implement healing and prosthetic protocol. Toll Free: 866-902-9272
Recall details
- Recall number
- Z-1818-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 9, 2017
- Posted by the FDA
- Apr 13, 2017
- Recalling firm
- Keystone Dental Inc
- Quantity
- 59 units
- Product code
- DZE
- FDA submissions
- K051614
- Distribution
- CA, IL, IN, FL, MA, MN, NJ, NV, PA,
Product description
Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
Code information (models, lots, serial numbers)
Lot Number: 30214
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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