FDAFDA · Food and drugs·Recall number Z-2085-2016
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.
Published July 6, 2016 · Recall initiated: May 13, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
- Distributor
- 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.
- Lot
- All Serial Numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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