Smith & Nephew Recalls TC-PLUS Knee Prosthesis Due to Dimensional Deviation
Smith & Nephew is recalling specific TC-PLUS knee prostheses because a dimensional deviation may prevent surgeons from seating 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 involves a high-risk medical device (knee prosthesis) with a defect that could prevent proper surgical implantation, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smith & Nephew, Inc. is recalling one unit of the TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 0012, S&N 7500267. The affected device is a tibial knee prosthesis manufactured by Smith & Nephew Orthopaedics AG.
The recall was initiated because the affected devices may contain a dimensional deviation. This issue could potentially result in the surgeon being unable to seat the polyethylene (PE) insert on the affected VKS tibial base plate during surgery.
The distribution pattern for this recall is international, limited to Germany and Switzerland. The specific batch number is C1507672. 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 8 RIGHT, STERILE R, REF 12 000 0012, S&N 7500267, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 1
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 C1507672
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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