Home / Recalls / Neocis, Inc. / Z-0929-2021

Z-0929-2021 Class II Terminated

Recalled by Neocis, Inc. — Miami, FL

Recall Details

Product Type
Devices
Report Date
February 3, 2021
Initiation Date
October 30, 2020
Termination Date
August 11, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
100 units

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.

Distribution Pattern

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

Code Information

Work Order (Lot) Number 1573

Other recalls by Neocis, Inc.

  • Z-2638-2020 Class II — DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Pr (May 14, 2020)
  • Z-2637-2020 Class II — DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Pr (May 14, 2020)
  • Z-2639-2020 Class II — DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Pro (May 14, 2020)
  • Z-0511-2020 Class II — Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance Syste (October 4, 2019)