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Recall Observatory FDA recall evidence

Device product

SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps parallel to the skin with the angled jaws forming a "V" shape between clamp and drape.

Z-2316-2015

June 16, 2015

Class II

Product summary

Firm
Symmetry Surgical, Inc.
Event
Event 71300
Status
Terminated
Classification
Class II
Quantity
2,708 units
Official record key
device-enforcement:Z-2316-2015

Official wording

Reason: Lack of sterility assurance.

Code information: 149053, 149129, 149143, 149604, 149605, 149606, 149682, 149692, 149837, 149853, 154454, 154455, 154456, 154457, 185696, 228161, 229609, 230233, 259154, 259156, 259160, 268906, 268910, and 271548.

Distribution pattern: Worldwide Distribution -- US, including the states of CA, VA, TX, FL, OH, NY, MS, KY, UT, GA, PA, MO, IN, NV, AL, MI, MA, and LA; and, the countries of Germany and Mexico.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility