FDA (Devices) recall action 78727
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
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 two units of the EMPOWR Tibial Punch because the guide did not sufficiently direct the punch, causing implants to be placed further back than intended.
Encore Medical is recalling two units of the EMPOWR Porous Knee System Tibial Punch because the locking guide failed to properly guide the punch, causing implants to be placed 2-3mm more posterior than intended.
Encore Medical is recalling 2 units of the DJO EMPOWR Knee Locking Tibial Punch Guide because the device did not sufficiently guide the punch, causing implants to be placed 2-3mm more posterior than intended.
Encore Medical is recalling two units of the EMPOWR Tibial Punch because the locking guide failed to properly position the implant.