Miami, FL, United States
Neocis Inc. recalls
3 recalls recorded since 2018, most recently on 30 October 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 30 October 2020
- Terminated
- 11 August 2021
- Reason
- The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.
- Distribution
- OH, FL, CT, MA, AZ PA, NY
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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)
Terminated Class II Medical devices
- Recall started
- 14 May 2020
- Terminated
- 27 July 2021
- Reason
- The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
- Distribution
- US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2638-2020, Z-2637-2020, Z-2639-2020
- DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implant
- 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 implant
- 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 implanta
Terminated Class II Medical devices
- Recall started
- 4 October 2019
- Terminated
- 5 October 2020
- Reason
- The Fiducial Array may mismatch their measurement files resulting in failed landmark check.
- Distribution
- US Nationwide distribution in the states of AR, OK, NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0511-2020
- 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 (intraope
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.