Smith & Nephew Recalls TC-PLUS Knee Prosthesis Components
Smith & Nephew is recalling 33 units of TC-PLUS tibial knee prosthesis components due to a dimensional deviation that may prevent proper assembly 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, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Smith & Nephew, Inc. is recalling 33 units of TC-PLUS(TM) Primary Fixed Tibial Component VKS Right, Size 6 Right, Sterile R, Reference 12 000 025, Serial Number 7500280. The affected devices are tibial knee prostheses manufactured by Smith & Nephew Orthopaedics AG.
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 agency has classified this recall as Class II.
The affected units were distributed internationally only in Germany and Switzerland. The specific batch numbers involved are B1500308, B1504018, and B1500952. Healthcare providers and patients should contact Smith & Nephew for further instructions regarding the replacement or return of these devices.
The recalled product
- Product
- TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 025, S&N 7500280, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 33
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 (3)
- Batch numbers: B1500308
- B1504018
- B1500952
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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