Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
Reported: September 20, 2023 Initiated: April 10, 2023 #Z-2580-2023
Product Description
Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
Reason for Recall
The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed with the kit were correctly labeled as Hard Line materials
Details
- Recalling Firm
- Keystone Industries
- Units Affected
- 240 units
- Distribution
- US Nationwide distribution in the states of IL, PA, FL NV, TX.
- Location
- Gibbstown, NJ
Frequently Asked Questions
What product was recalled? ▼
Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718. Recalled by Keystone Industries. Units affected: 240 units.
Why was this product recalled? ▼
The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed with the kit were correctly labeled as Hard Line materials
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 20, 2023. Severity: Moderate. Recall number: Z-2580-2023.
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