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Recall Observatory FDA recall evidence

Device product

Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S

Z-0707-2022

January 28, 2022

Class II

Product summary

Firm
Brasseler USA, Medical L.L.C.
Event
Event 89555
Status
Terminated
Classification
Class II
Quantity
231 units
Official record key
device-enforcement:Z-0707-2022

Official wording

Reason: One lot of product was distributed in unsealed packaging

Code information: UDI (01)00887919491033(17)260719(10)NV1MX Lot Code NV1MX

Distribution pattern: US Nationwide distribution in the states of OH, MI, AZ, FL, CA, TN, TX, SC, PA IL, ID.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    unsealed packaging