FDA (Devices) recall action 80845
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
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.
Orthosensor, Inc. is recalling 41 VERASENSE sensors for Zimmer Biomet Persona CR E-F/3-11 Left knees because fluid was reported inside the posterior lateral corner after surgery.
Orthosensor, Inc. is recalling 37 VERASENSE sensors for Zimmer Biomet Persona CR E-F/3-11 Right knees because fluid was reported inside the posterior lateral corner post-surgery.
Orthosensor, Inc. is recalling 68 VERASENSE sensors for Zimmer Biomet Persona CR G-H/7-12 Right because fluid was reported inside the posterior lateral corner post-surgery.
Orthosensor, Inc. is recalling 36 VERASENSE sensors for Zimmer Biomet Persona CR C-D/3-9 Right knees because fluid was reported inside the posterior lateral corner post-surgery.
Orthosensor, Inc. is recalling 84 VERASENSE sensors for Zimmer Biomet Persona CR G-H/7-12 Left because fluid was reported inside the posterior lateral corner post-surgery.
Orthosensor, Inc. is recalling 56 VERASENSE sensors for Zimmer Biomet Persona CR C-D/3-9 Left because some were reported to have fluid inside the posterior lateral corner post-surgery.