Z-0299-2017Class II

Keystone Dental PrimaConnex Straight Implant TC, RD Internal Connection 4.0 x 11.5mm

Name: Z-0299-2017 Keystone Dental PrimaConnex Straight Implant TC, RD Internal Connection 4.0 x 11.5mm
Creator: Keystone Dental Inc
Published: 2016-09-15
License: https://open.fda.gov/license/

Keystone Dental Inc. / initiated 2016-09-15 / Terminated / root cause: packaging

FDA source

Keystone Dental Inc began a recall of 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... on 2016-09-15. FDA classified it as Class II and gives the reason as "Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0299-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-15
Posted: 2016-10-21
Terminated: 2017-01-03
Recalling firm: Keystone Dental Inc.
Product: 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
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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.
Quantity in commerce: 55 units
Distribution: Worldwide distribution - US (Nationwide Distribution to CA, CO, IL, MA, MN, ND, NY, NV, PA, and VA.) and Italy
Product codes and lots: Lot # 27714

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0299-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0299-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-21

Product code DZE

K051614Class IIPrimaconnex Internal Connection Implant System, Primaconnex Internal Connection ProstheticsLifecore Biomedical, Inc. / cleared 2005-09-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)