Z-0929-2021 Class II Terminated
FDA device recall Z-0929-2021 was initiated by Neocis, Inc. on October 30, 2020 and is designated Class II. Reason for recall: The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled. The recall status is terminated (terminated August 11, 2021). Affected quantity: 100 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 3, 2021
- Initiation Date
- October 30, 2020
- Termination Date
- August 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 units
Product Description
DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
Reason for Recall
The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.
Distribution Pattern
OH, FL, CT, MA, AZ PA, NY
Code Information
Work Order (Lot) Number 1573