Medical device recalls Moderate risk

Mako Surgical Corporation recalls 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)

Recall date
April 25, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1824-2019
FDA classification
Class II
Brand / firm
Mako Surgical Corporation
Sold / distributed
AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands

Why it was recalled

The bearings of the saw attachments were ungreased.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)

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