Z-0929-2021Class II

DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system...

Name: Z-0929-2021 DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system...
Creator: Neocis, Inc.
Published: 2020-10-30
License: https://open.fda.gov/license/

Neocis Inc. / initiated 2020-10-30 / Terminated / root cause: manufacturing process

FDA source

Neocis, Inc. began a recall of DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS) on 2020-10-30. FDA classified it as Class II and gives the reason as "The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0929-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-30
Posted: 2021-01-26
Terminated: 2021-08-11
Recalling firm: Neocis Inc.
Product: DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
Product code: PLV Dental Stereotaxic Instrument
Reason for recall: The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 100 units
Distribution: OH, FL, CT, MA, AZ PA, NY
Product codes and lots: Work Order (Lot) Number 1573

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0929-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0929-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-26

Product code PLV

K173402Class IINeocis Guidance System (NGS) with Chairside SplintNeocis, Inc. / cleared 2018-02-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)