Smith & Nephew, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1545-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 11, 2016

Date Posted: April 27, 2016

Recall Number: Z-1545-2016

Event ID: 73609

Reason for Recall:

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.

Status: Terminated

Product Quantity: 22 units

Code Information:

Batch numbers: B1510531, B1506602, B1502407

Distribution Pattern:

International Distribution only in countries of: Germany and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated