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Recall Observatory FDA recall evidence

Device product

Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718

Z-2580-2023

April 10, 2023

Class II

Product summary

Firm
Keystone Industries
Event
Event 92856
Status
Ongoing
Classification
Class II
Quantity
240 units
Official record key
device-enforcement:Z-2580-2023

Official wording

Reason: 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

Code information: UDI: +H65857007171/$$325120723B058BP Lot Number: 23B058B

Distribution pattern: US Nationwide distribution in the states of IL, PA, FL NV, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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