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Recall Observatory FDA recall evidence

Device product

Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic

Z-1854-2017

March 09, 2017

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 76729
Status
Terminated
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-1854-2017

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 15HM05197

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