Smith & Nephew Recalls TC-Plus Tibial Knee Prosthesis Components
Smith & Nephew is recalling four 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 involves a high-risk medical device where a defect could prevent proper surgical implantation, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Smith & Nephew, Inc. is recalling four units of the TC-Plus Primary Fixed Tibial Component VKS Right, Size 6 Right, Sterile R. The specific product reference is 12 000 0011, with serial number 7500266 and batch number C1507159.
The recall is due to a dimensional deviation in the affected devices. 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 affected devices were distributed internationally only in Germany and Switzerland. No illnesses or injuries have been reported in the source text.
The recalled product
- Product
- TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 0011, S&N 7500266, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 4
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 C1507159
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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