Smith & Nephew Recalls TC-PLUS Tibial Knee Prosthesis Components
Smith & Nephew is recalling six units of TC-PLUS tibial knee prosthesis components due to a dimensional deviation that may prevent the polyethylene insert from seating correctly 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 medical device with a risk of harm (inability to seat the implant during surgery) where no injuries have been reported, fitting the rubric for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Smith & Nephew, Inc. is recalling six units of the TC-PLUS(TM) Primary Fixed Tibial Component VKS Left, Size 8 Left, Sterile R (REF 12 000 005, S&N 7500260). The affected devices are identified by batch number C1507158. These devices were distributed internationally only in Germany and Switzerland.
The recall is due to a potential dimensional deviation in the tibial base plate. This deviation could 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 report any injuries, illnesses, or deaths associated with this recall.
Hospitals and surgical centers in Germany and Switzerland that have received these specific units should stop using them and contact Smith & Nephew for further instructions. Consumers who have had these specific implants placed should contact their healthcare provider for guidance.
The recalled product
- Product
- TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 005, S&N 7500260, 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 (1)
- Batch number C1507158
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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