FDAFDA · Food and drugs·Recall number Z-1545-2016
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
Published April 27, 2016 · Recall initiated: March 11, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smith & Nephew, Inc.
- Distributor
- International Distribution only in countries of: Germany and Switzerland.
- Lot
- Batch numbers: B1510531, B1506602, B1502407
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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