Recall Z-1538-2016— Smith & Nephew, Inc.

Name: FDA recall Z-1538-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-11

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2016-03-11, terminated 2017-04-10. It names one FDA 510(k) clearance: K072858. 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. Reason: 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..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-03-11
Terminated: 2017-04-10
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K072858 — TC-PLUS PRIMARY KNEE SYSTEMSmith & Nephew, Inc.·cleared 2007-11-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.