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Recall Observatory FDA recall evidence

Device product

EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments.

Z-2945-2020

August 24, 2020

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 86342
Status
Terminated
Classification
Class II
Quantity
71 units
Official record key
device-enforcement:Z-2945-2020

Official wording

Reason: Multiple or incorrect expiration dates were provided on the affected designation labels.

Code information: Part Numbers: 72424030, 72424010, 72424012, 72424016, 72424018, 72424020, 72424022, 72424024, 72434026, 72434028, 72434030, 72423014, 72423016, 72434065, 72434070, 72434075, 72412465, 72424032, 72424040, 72424055, 72424075, 72424080, 72423044. Batch/Lots: 14FM17199R, 14FM01226R, 14FM01227R, 14FM02610R, 14FM03418R, 14FM03420R, 14FM03422R, 14FM03424R, 14FM13578R, 14FM13580R, 14FM13581R, 14FM15166R, 14FM15167R, 14FM16225R, 14FM16228R, 14FM16229R, 14FM16386R, 14FM17201R, 14FM18527R, 14FM19218R, 14FM19226R, 14FM19229R, 14FM19360R.

Distribution pattern: International Distribution to the countries of Denmark, Sweden, France and Spain.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Multiple or incorrect expiration dates were provided on the affected designation labels.