Neocis, Inc.

FDA recalling firm · 3 enforcement events · 5 product records · 2019–2020 · FL

Neocis, Inc. has 3 FDA enforcement events on this register (5 product records) between 2019 and 2020: 3 device; the busiest year was 2020 with 2.

0% of its events are Class I; the most common class is Class II (3). 0 events are listed as ongoing; the recalling firm's address is in FL.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
30 Oct 2020	DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)	Device	Class II	1	Terminated
14 May 2020	DRW-0739-01: Gen 2 Posterior 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.	Device	Class II	3	Terminated
4 Oct 2019	Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intraoperative) phases of dental implantation surgery. The system provides software to preoperatively plan…	Device	Class II	1	Terminated

By type and class

Device3

Class II3

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Neocis, Inc. by year initiated.

Questions and answers

How many FDA recalls has Neocis, Inc. had?

3 enforcement events (5 product records) on this register, 2019–2020: 3 device.

Are any Neocis, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Neocis, Inc. recalls?

3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.