FDA (Devices) recall action 85943
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.
There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensure accurate preparation seem to be contributing to this situation. There is a potential of a delay in surgery if this issue were to recur.
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.
Encore Medical is recalling 28 units of the EMPOWR Partial Knee Peg Drill Guide because the drill shaft may bind during use, potentially delaying surgery.
Encore Medical is recalling 28 units of the EMPOWR Partial Knee Peg Drill because the shaft may bind within the guide, potentially delaying surgery.