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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where the hazard is a potential surgical complication (inability to seat insert) without reported injuries or illnesses.
Plain-English summary
Smith & Nephew, Inc. is recalling one unit of the TC-Plus(TM), Primary Fixed Tibial Component VKS Right, Size 10 Right, Sterile R. The specific unit is identified by Reference 12 000 027, Serial Number 7500282, and Batch Number B1505699. The product is a tibial knee prosthesis manufactured by Smith & Nephew Orthopaedics AG.
The recall is due to a potential dimensional deviation in the affected devices. This deviation could result in the surgeon being unable to seat the polyethylene (PE) insert on the VKS tibial base plate during surgery. The agency has classified this recall as Class II.
The affected unit was distributed internationally only in Germany and Switzerland. No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take.
The recalled product
- 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
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch number B1505699
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 15 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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