DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
Reported: February 3, 2021 Initiated: October 30, 2020 #Z-0929-2021
Product Description
DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
Reason for Recall
The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.
Details
- Recalling Firm
- Neocis, Inc.
- Units Affected
- 100 units
- Distribution
- OH, FL, CT, MA, AZ PA, NY
- Location
- Miami, FL
Frequently Asked Questions
What product was recalled? ▼
DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS). Recalled by Neocis, Inc.. Units affected: 100 units.
Why was this product recalled? ▼
The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 3, 2021. Severity: Moderate. Recall number: Z-0929-2021.
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