FDA (Devices) recall action 82738
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
The bearings of the saw attachments were ungreased.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Mako Surgical Corporation is recalling 39 units of the 2.7 Degree Angled Sagittal Saw attachment because the bearings were ungreased.
Mako Surgical Corporation is recalling 2.7 Degree Straight Sagittal Saw attachments because the bearings were ungreased. The devices were distributed to facilities in 13 US states and three international countries.