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Terminated

Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K

FDA Recall Z-1818-2017 · Posted 2017-04-13

Recalling FirmKeystone Dental Inc
Recall StatusTerminated
Product CodeDZE
Date Initiated2017-03-09
Date Terminated2017-07-05
Product Quantity59 units

Reason for Recall

Straight PrimaConnex Implants contained Tapered PrimaConnex Implants

Firm Action

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

Root Cause

Labeling mix-ups

Distribution Pattern

CA, IL, IN, FL, MA, MN, NJ, NV, PA,

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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