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Recall Observatory FDA recall evidence

Device product

6.5MMX165MM CANNULATED SCREW

Z-0143-2022

September 20, 2021

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 88773
Status
Terminated
Classification
Class II
Quantity
5 units
Official record key
device-enforcement:Z-0143-2022

Official wording

Reason: The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.

Code information: Model 71106365S; Lot 20GT39417

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of OK, TN and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.