Device product
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.
Z-2637-2020
Product summary
- Firm
- Neocis Inc.
- Event
- Event 85856
- Status
- Terminated
- Classification
- Class II
- Quantity
- 70 units
- Official record key
device-enforcement:Z-2637-2020
Official wording
Reason: The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
Code information: Work Order (lot): 1619 and 1620
Distribution pattern: US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH
Derived failure modes
-
Labeling or packaging
mislabeled