Z-2639-2020Class II

DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) -

Name: Z-2639-2020 DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) -
Creator: Neocis Inc.
Published: 2020-05-14
License: https://open.fda.gov/license/

Neocis Inc. / initiated 2020-05-14 / Terminated / root cause: manufacturing process

FDA source

Neocis Inc. began a recall of DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative)... on 2020-05-14. FDA classified it as Class II and gives the reason as "The LRUL and LLUR posterior chairside splints and 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-2639-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-14
Posted: 2020-07-16
Terminated: 2021-07-27
Recalling firm: Neocis Inc.
Product: DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
Product code: PLV Dental Stereotaxic Instrument
Reason for recall: The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customers were notified via UPS overnight mail sent 05/19/2020. Notification also included a site visit from the Neocis Clinical Sales Representative or Neocis Field Clinical Engineer. Customers are asked to stop use of the Gen II Posterior Splints until a trained person from Neocis has inspected their inventory. 100% effectiveness checks are planned.
Quantity in commerce: 50 units
Distribution: US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH
Product codes and lots: Work Order (lot): 1623

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2639-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2637-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-16
Z-2638-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-16
Z-2639-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-16

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)