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Terminated

PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.

FDA Recall Z-0973-2013 · Posted 2013-03-20

Recalling FirmKeystone Dental Inc
Recall StatusTerminated
Product CodeNDP
Date Initiated2013-03-11
Date Terminated2013-09-26
Product Quantity120 units

Reason for Recall

Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled

Firm Action

Keystone Dental initially called customers on 3/11/13 and forms were completed to document these calls. In addition, a letter sent via Federal Express/or hand delivered to all distributors and customers. Product requested to be returned.

Root Cause

Packaging process control

Distribution Pattern

Worldwide Distribution-USA including DC and the states of CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI, and NY, and the countries of Republic of China, Germany, and France.

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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