Recall Z-0929-2021— Neocis, Inc.

Name: FDA recall Z-0929-2021
Creator: U.S. Food and Drug Administration
Published: 2020-10-30

Class II · Terminated

Class II FDA medical device recall by Neocis, Inc., initiated 2020-10-30, terminated 2021-08-11. It names one FDA 510(k) clearance: K173402. Product: DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS). Reason: The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled..

Recalling firm: Neocis, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-10-30
Terminated: 2021-08-11
Firm location: Miami, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K173402 — Neocis Guidance System (NGS) with Chairside SplintNeocis, Inc.·cleared 2018-02-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.