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Recall Observatory FDA recall evidence

Device product

Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130

Z-0827-2020

September 16, 2019

Class II

Product summary

Firm
Medicrea International
Event
Event 84595
Status
Ongoing
Classification
Class II
Quantity
30 units
Official record key
device-enforcement:Z-0827-2020

Official wording

Reason: Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded

Code information: Lot number(s) : 18G0037

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded