Smith & Nephew Recalls TC-PLUS Tibial Knee Prosthesis Components
Smith & Nephew is recalling three 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 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, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smith & Nephew, Inc. is recalling three units of the TC-PLUS(TM) Primary Fixed Tibial Component VKS Left, Size 10 Left, Sterile R. The specific units are identified by Reference 12 000 006, Serial Number 7500261, and Batch Number C1507675. These 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 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 beyond the identification of the affected units.
The recalled product
- Product
- TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12 000 006, S&N 7500261, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 3
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 C1507675
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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