Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 — recall Z-1546-2016

U.S. FDA — Device Enforcement · United States · 2016-03-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1546-2016
Date of alert
2016-03-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Smith & Nephew, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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