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Terminated

DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.

FDA Recall Z-2638-2020 · Posted None

Recalling FirmNeocis Inc.
Recall StatusTerminated
Product CodePLV
Date Initiated2020-05-14
Date Terminated2021-07-27
Product Quantity70 units

Reason for Recall

The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.

Firm Action

Customers were notified via UPS overnight mail sent 05/19/2020. Notification also included a site visit from the Neocis Clinical Sales Representative or Neocis Field Clinical Engineer. Customers are asked to stop use of the Gen II Posterior Splints until a trained person from Neocis has inspected their inventory. 100% effectiveness checks are planned.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K173402Neocis Guidance System (NGS) with Chairside SplintNeocis, Inc. · 2018-02-22

Official Source

View FDA Recall →

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

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