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Recall Observatory FDA recall evidence

Device product

Strauss Penis Clamp 130MM/General Instruments

Z-1359-2018

February 16, 2018

Class III

Product summary

Firm
Aesculap Implant Systems LLC
Event
Event 79656
Status
Terminated
Classification
Class III
Quantity
Unavailable
Official record key
device-enforcement:Z-1359-2018

Official wording

Reason: The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.

Code information: EF401R

Distribution pattern: nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.