Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0299-2017 — 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 overd

U.S. FDA — Device Enforcement · United States · 2016-09-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0299-2017
Date of alert: 2016-09-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Keystone Dental Inc
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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