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Recall Observatory FDA recall evidence

Device product

Restrata, Part Number RWM1-2X2

Z-1030-2022

March 21, 2022

Class II

Product summary

Firm
Acera Surgical Inc
Event
Event 89919
Status
Terminated
Classification
Class II
Quantity
83 units
Official record key
device-enforcement:Z-1030-2022

Official wording

Reason: Misprinted expiration date on the shelf-box

Code information: Lot Number 51745 UDI (01) 8 52425800 60682 (10) 51745 (17) 220218 (21) 0068

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Misprinted expiration date on the shelf-box