FDA (Devices) recall action 73609

Smith & Nephew, Inc. recalled 15 products on 2016-04-27

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.

Products: 15
Announced: 2016-04-27
Critical: 0
Units: 191

Why these products were recalled

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.

1–15 of 15

HighFDA (Devices)··2016-04-27
Smith & Nephew Recalls TC-Plus Tibial Knee Components Due to Dimensional Deviation
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.
Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000 018, S&N 7500273, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Category
Distribution
0 states
HighFDA (Devices)··2016-04-27
Smith & Nephew Recalls TC-Plus Tibial Knee Prosthesis Components
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.
Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 0013, S&N 7500268, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Category
Distribution
0 states
HighFDA (Devices)··2016-04-27
Smith & Nephew Recalls TC-Plus Tibial Knee Prosthesis Components
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.
Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 7500272, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Category
Distribution
0 states
HighFDA (Devices)··2016-04-27
Smith & Nephew Recalls TC-Plus Knee Prosthesis Due to Dimensional Deviation
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.
Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE R, REF 12 000 009, S&N 7500264, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Category
Distribution
0 states
HighFDA (Devices)··2016-04-27
Smith & Nephew Recalls TC-PLUS Tibial Knee Prosthesis Components
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.
Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE R, REF 12 000 024, S&N 7500279, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Category
Distribution
0 states
HighFDA (Devices)··2016-04-27
Smith & Nephew Recalls TC-Plus Tibial Knee Prosthesis Components
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.
Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 026, S&N 7500281, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Category
Distribution
0 states
HighFDA (Devices)··2016-04-27
Smith & Nephew Recalls TC-Plus Knee Prosthesis Due to Dimensional Deviation
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.
Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 027, S&N 7500282, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Category
Distribution
0 states
HighFDA (Devices)··2016-04-27
Smith & Nephew Recalls TC-PLUS Knee Prosthesis Due to Dimensional Deviation
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.
Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 019, S&N 7500274, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Category
Distribution
0 states
SevereFDA (Devices)··2016-04-27
Smith & Nephew Recalls TC-PLUS Knee Prosthesis Due to Dimensional Deviation
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.
Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N 7500283, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Category
Distribution
0 states
HighFDA (Devices)··2016-04-27
Smith & Nephew Recalls TC-PLUS Tibial Knee Prosthesis Components
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.
Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 005, S&N 7500260, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Category
Distribution
0 states
HighFDA (Devices)··2016-04-27
Smith & Nephew Recalls TC-PLUS Knee Prosthesis Due to Dimensional Deviation
Smith & Nephew is recalling specific TC-PLUS knee prostheses because a dimensional deviation may prevent surgeons from seating the polyethylene insert during surgery.
Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 0012, S&N 7500267, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Category
Distribution
0 states
HighFDA (Devices)··2016-04-27
Smith & Nephew Recalls TC-PLUS Tibial Knee Prosthesis Components
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.
Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12 000 006, S&N 7500261, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Category
Distribution
0 states
HighFDA (Devices)··2016-04-27
Smith & Nephew Recalls TC-PLUS Knee Prosthesis Components
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.
Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 025, S&N 7500280, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Category
Distribution
0 states
HighFDA (Devices)··2016-04-27
Smith & Nephew Recalls TC-PLUS Knee Prosthesis Due to Dimensional Deviation
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.
Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000 002, S&N 7500257, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Category
Distribution
0 states
HighFDA (Devices)··2016-04-27
Smith & Nephew Recalls TC-Plus Tibial Knee Prosthesis Components
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.
Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 0011, S&N 7500266, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Category
Distribution
0 states