Smith & Nephew Recalls TC-Plus Tibial Knee Prosthesis Components
Smith & Nephew is recalling 6 units of TC-Plus tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating of the polyethylene insert 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. The hazard involves a potential surgical complication (inability to seat the insert) which is a risk-of-harm scenario where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Smith & Nephew, Inc. is recalling 6 units of the TC-Plus Primary Fixed Tibial Component VKS Right, Size 10 Right, Sterile R (Reference 12 000 0013, Serial Number 7500268). The affected devices are tibial knee prostheses manufactured by Smith & Nephew Orthopaedics AG.
The recall is being issued 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 recall is classified as Class II by the U.S. Food and Drug Administration. The distribution pattern for these specific units was international, limited to Germany and Switzerland. No specific instructions for consumers or healthcare providers are provided in the source text beyond the identification of the affected units.
The recalled product
- Product
- TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 0013, S&N 7500268, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 6
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 C1507674
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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