Food, drugs, devices › Neocis, Inc.
Device recall: DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis
Neocis, Inc. (Miami, FL) initiated this device recall on 30 Oct 2020; FDA lists 1 product record under event 87060, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 11 Aug 2021. Initiation: voluntary: firm initiated. Neocis, Inc. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Neocis, Inc., Miami, FL.
Reason for recall
"The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled."
Distribution
"OH, FL, CT, MA, AZ PA, NY"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0929-2021 | DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS) | 100 units | Class II | Terminated | 3 Feb 2021 |
Context
Other enforcement events for Neocis, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 14 May 2020 | DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assista | Device | Class II | 3 |
| 4 Oct 2019 | Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational s | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "OH, FL, CT, MA, AZ PA, NY"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 Aug 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.