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Recall Observatory FDA recall evidence

Device product

Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701

Z-1239-2017

February 02, 2017

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 76414
Status
Terminated
Classification
Class II
Quantity
2646
Official record key
device-enforcement:Z-1239-2017

Official wording

Reason: The single use devices are provided sterile and do not have an expiration date on the label.

Code information: Batch Numbers: 50586138 50458123 50418120 50339534 50306882 50285907 50248565 50231427 50197615 50171397 50158655 50138049 50119457 50089297 50082581 50069485

Distribution pattern: Nationwide Foreign: Brazil, Canada, Chile , China, Denmark, Hong Kong, India, Mexico, Peru, Singapore, Venezuela

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The single use devices are provided sterile and do not have an expiration date on the label.