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

Z-0929-2021 Class II Terminated

Recalled by Neocis, Inc. — Miami, FL

FDA device recall Z-0929-2021 was initiated by Neocis, Inc. on Oct 30, 2020 and is designated Class II. Reason for recall: The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled. The recall status is terminated (terminated Aug 11, 2021). Affected quantity: 100 units.

Recall details

Product Type: Devices
Report Date: Feb 3, 2021
Initiation Date: Oct 30, 2020
Termination Date: Aug 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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0929-2021
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Neocis, Inc.

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