Smith & Nephew Recalls TC-Plus Tibial Knee Prosthesis Components
Smith & Nephew is recalling 34 units of TC-Plus tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating 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, but no injuries or illnesses have been reported.
Plain-English summary
Smith & Nephew, Inc. is recalling 34 units of TC-Plus(TM) Primary Fixed Tibial Component VKS Right, Size 8 Right, Sterile R. The affected devices are identified by Reference 12 000 026 and Serial Number 7500281. The recall covers specific batch numbers: B1514883, B1509344, B1504926, and B1502141.
The recall was initiated 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 illnesses or injuries have been reported in the source text. Healthcare providers and patients should contact Smith & Nephew for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 026, S&N 7500281, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 34
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 (4)
- Batch numbers: B1514883
- B1509344
- B1504926
- B1502141
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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