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Recall Observatory FDA recall evidence

Device product

Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140

Z-0828-2020

September 16, 2019

Class II

Product summary

Firm
Medicrea International
Event
Event 84595
Status
Ongoing
Classification
Class II
Quantity
190 units
Official record key
device-enforcement:Z-0828-2020

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) : 18G0368; 19H0009; 18F0138; 18G0038

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