Recall Z-2637-2020— Neocis Inc.
Class II · Terminated
Class II FDA medical device recall by Neocis Inc., initiated 2020-05-14, terminated 2021-07-27. It names one FDA 510(k) clearance: K173402. 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.. Reason: The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled..
- Recalling firm
- Neocis Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-14
- Terminated
- 2021-07-27
- Firm location
- Miami, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.