Smith & Nephew Recalls TC-PLUS Knee Prosthesis Due to Dimensional Deviation
Smith & Nephew is recalling two units of the TC-PLUS Primary Fixed Tibial Component due to a dimensional deviation that may prevent the polyethylene insert from seating properly 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 (knee prosthesis) where a defect could prevent proper implantation during surgery, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Smith & Nephew, Inc. is recalling two units of the TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R (REF 12 000 002, S&N 7500257). The affected devices are identified by Batch Number C1507852. These devices were distributed internationally only in Germany and Switzerland.
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 source text does not specify instructions for consumers or healthcare providers regarding the disposal or return of these specific units, nor does it report any injuries or illnesses associated with the use of these devices.
The recalled product
- Product
- TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000 002, S&N 7500257, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 2
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 C1507852
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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