Smith & Nephew Recalls TC-PLUS Knee Prosthesis Due to Dimensional Deviation
Smith & Nephew is recalling 6 units of TC-PLUS tibial knee prostheses due to a dimensional deviation that may prevent the polyethylene insert from seating correctly during surgery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score (4) under the rubric, as it involves a defect that could cause temporary or medically reversible health consequences or require hospitalization.
Plain-English summary
Smith & Nephew, Inc. is recalling 6 units of the TC-PLUS(TM) Primary Fixed Tibial Component VKS Right, Size 12 Right, Sterile R (REF 12 000 028, S&N 7500283). The affected devices are tibial knee prostheses manufactured by Smith & Nephew Orthopaedics AG.
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 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 B1509884 and B1503362. Healthcare providers and facilities that may have received these specific units should contact Smith & Nephew, Inc. for further instructions on how to handle the affected devices.
The recalled product
- Product
- TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N 7500283, 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 (2)
- Batch numbers: B1509884
- B1503362
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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