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Recall Observatory FDA recall evidence

Device product

Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dissect bone in surgical applications.

Z-2085-2016

May 13, 2016

Class II

Product summary

Firm
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Event
Event 74275
Status
Terminated
Classification
Class II
Quantity
368 devices
Official record key
device-enforcement:Z-2085-2016

Official wording

Reason: Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.

Code information: All Serial Numbers.

Distribution pattern: Worldwide Distribution-Including the states of AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, MA, MD, NC, NH, NY, SC, TN, TX, and UT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.