Z-2639-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2020
- Initiation Date
- May 14, 2020
- Termination Date
- July 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
Product Description
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 implantation surgery.
Reason for Recall
The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
Distribution Pattern
US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH
Code Information
Work Order (lot): 1623