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Recall Observatory FDA recall evidence

Device product

VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045

Z-0566-2020

November 08, 2016

Class II

Product summary

Firm
Wright Medical Technology, Inc.
Event
Event 84180
Status
Terminated
Classification
Class II
Quantity
54 units
Official record key
device-enforcement:Z-0566-2020

Official wording

Reason: The firm discovered a lack of adequate documentation confirming sterility on certain products.

Code information: Lot Number 1547961

Distribution pattern: US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm discovered a lack of adequate documentation confirming sterility on certain products.