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Recall Observatory FDA recall evidence

Device product

D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic

Z-1855-2017

March 09, 2017

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 76729
Status
Terminated
Classification
Class II
Quantity
19 units
Official record key
device-enforcement:Z-1855-2017

Official wording

Reason: The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.

Code information: Batch number 15KM05493

Distribution pattern: Worldwide Distribution - US (Nationwide) Internationally to Colombia, Denmark, Finland, France, Great Britain, Italy, and Singapore

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    labeling are incorrect