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Recall Observatory FDA recall evidence

Device product

SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue

Z-2049-2014

June 02, 2014

Class II

Product summary

Firm
Smith & Nephew, Inc. Endoscopy Division
Event
Event 68565
Status
Terminated
Classification
Class II
Quantity
763 units
Official record key
device-enforcement:Z-2049-2014

Official wording

Reason: Sterility of device is compromised due to breach in sterile barrier

Code information: Lot Numbers: 50478984,50485736, 50485737, 50485738, 50487831, 50491901, 50493684

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    compromised due to breach in sterile barrier