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Terminated

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

FDA Recall Z-0299-2017 · Posted 2016-10-21

Recalling FirmKeystone Dental Inc
Recall StatusTerminated
Product CodeDZE
Date Initiated2016-09-15
Date Terminated2017-01-03
Product Quantity55 units

Reason for Recall

Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

Worldwide distribution - US (Nationwide Distribution to CA, CO, IL, MA, MN, ND, NY, NV, PA, and VA.) and Italy

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051614PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICSLifecore Biomedical, Inc. · 2005-09-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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