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Terminated

DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)

FDA Recall Z-0929-2021 · Posted None

Recalling FirmNeocis, Inc.
Recall StatusTerminated
Product CodePLV
Date Initiated2020-10-30
Date Terminated2021-08-11
Product Quantity100 units

Reason for Recall

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

Firm Action

The firm initiated the recall by letter on 10/30/2020 via UPS overnight delivery. The letter explains the issue, refers to the original recall and requests that the consignee set aside any affected product. Neocis Field Personnel will inspect the devices and return them to the manufacturing facility.

Root Cause

Process control

Distribution Pattern

OH, FL, CT, MA, AZ PA, NY

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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