Smith & Nephew Recalls TC-PLUS Knee Prosthesis Due to Dimensional Deviation
Smith & Nephew is recalling 15 units of TC-PLUS Primary Fixed Tibial Components due to a dimensional deviation that may prevent proper seating of the polyethylene insert.
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 the insert) without reported injuries or illnesses.
Plain-English summary
Smith & Nephew, Inc. is recalling 15 units of the TC-PLUS(TM) Primary Fixed Tibial Component VKS Left, Size 8 Left, Sterile R. The affected devices are identified by Reference 12 000 019 and Serial Number 7500274, with batch numbers B1506274 and B1501722. These devices are tibial knee prostheses manufactured by Smith & Nephew Orthopaedics AG.
The recall is being conducted because the affected devices may contain a dimensional deviation. This deviation could potentially result in the surgeon being unable to seat the polyethylene (PE) insert on the affected VKS tibial base plate during surgery. The agency has classified this recall as Class II.
The affected devices were distributed internationally only in Germany and Switzerland. No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions, but the recall indicates a potential issue with the device's fit during surgical implantation.
The recalled product
- Product
- 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
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 15
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 (2)
- Batch numbers: B1506274
- B1501722
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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