Device product
DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
Z-0929-2021
Product summary
- Firm
- Neocis, Inc.
- Event
- Event 87060
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 units
- Official record key
device-enforcement:Z-0929-2021
Official wording
Reason: The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.
Code information: Work Order (Lot) Number 1573
Distribution pattern: OH, FL, CT, MA, AZ PA, NY
Derived failure modes
-
Labeling or packaging
mislabeled