FDA (Devices) recall action 73609
The FDA (Devices) publishes a recall like this one as 15 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 15 pages.
The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.
The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during 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.
Smith & Nephew is recalling 34 units of TC-Plus tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating during surgery.
Smith & Nephew is recalling 6 units of TC-Plus tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating of the polyethylene insert during surgery.
Smith & Nephew is recalling specific TC-Plus knee prostheses distributed in Germany and Switzerland because a dimensional deviation may prevent the polyethylene insert from seating correctly during surgery.
Smith & Nephew is recalling 33 units of TC-PLUS tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating of the polyethylene insert during surgery.
Smith & Nephew is recalling one unit of a TC-Plus knee prosthesis due to a dimensional deviation that may prevent the polyethylene insert from seating correctly during surgery.
Smith & Nephew is recalling specific TC-PLUS knee prostheses because a dimensional deviation may prevent surgeons from seating the polyethylene insert during surgery.
Smith & Nephew is recalling 33 units of TC-PLUS tibial knee prosthesis components due to a dimensional deviation that may prevent proper assembly during surgery.
Smith & Nephew is recalling two units of the TC-PLUS Primary Fixed Tibial Component due to a dimensional deviation that may prevent the polyethylene insert from seating properly during surgery.
Smith & Nephew is recalling four units of TC-Plus tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating during surgery.
Smith & Nephew is recalling 24 units of TC-Plus tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating during surgery.
Smith & Nephew is recalling 15 units of TC-PLUS Primary Fixed Tibial Components due to a dimensional deviation that may prevent proper seating of the polyethylene insert.
Smith & Nephew is recalling 22 units of TC-Plus tibial knee components distributed in Germany and Switzerland due to a dimensional deviation that may prevent proper seating of the polyethylene insert.
Smith & Nephew is recalling 6 units of TC-PLUS tibial knee prostheses due to a dimensional deviation that may prevent the polyethylene insert from seating correctly during surgery.
Smith & Nephew is recalling six units of TC-PLUS tibial knee prosthesis components due to a dimensional deviation that may prevent the polyethylene insert from seating correctly during surgery.
Smith & Nephew is recalling three TC-PLUS tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating of the polyethylene insert during surgery.