FDA (Devices) recall action 91102
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.
One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.
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.
MicroPort Orthopedics is recalling EVOLUTION MP Tibial Base knee prosthesis components due to a packaging error where a wrong-sized component was placed inside product boxes. One incident was discovered during surgery.
MicroPort Orthopedics is recalling lot 1916715 of EVOLUTION MP Tibial Bases (size 7) due to a packaging error where the wrong-sized implant component was found in a package. A confirmed incident involved discovery during surgery.