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Terminated

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.

FDA Recall Z-2085-2016 · Posted 2016-06-28

Recalling FirmMedtronic Sofamor Danek Usa, Inc - Dallas Distribution
Recall StatusTerminated
Product CodeHBE
Date Initiated2016-05-13
Date Terminated2017-06-13
Product Quantity368 devices

Reason for Recall

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

Firm Action

Recall notification letters were sent to consignees on 05/13/2016.

Root Cause

Device Design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081475ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]Medtronic Xomed, Inc. · 2008-10-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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