DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
Reported: July 22, 2020 Initiated: May 14, 2020 #Z-2638-2020
Product Description
DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - 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.
Details
- Recalling Firm
- Neocis Inc.
- Units Affected
- 70 units
- Distribution
- US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH
- Location
- Miami, FL
Frequently Asked Questions
What product was recalled? ▼
DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.. Recalled by Neocis Inc.. Units affected: 70 units.
Why was this product recalled? ▼
The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 22, 2020. Severity: Moderate. Recall number: Z-2638-2020.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11