Smith & Nephew Recalls TC-Plus Tibial Knee Prosthesis Components
Smith & Nephew is recalling 24 units of TC-Plus tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating 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 potential functional failure during surgery, which fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smith & Nephew, Inc. is recalling 24 units of TC-Plus Primary Fixed Tibial Component VKS Left, Size 4 Left, Sterile R. The affected devices are identified by reference number 12 000 017 and serial number 7500272, with batch numbers B1508762, B1504644, and B1500721.
The recall was initiated because the affected devices may contain a dimensional deviation. This deviation could potentially result in the surgeon being unable to seat the polyethylene insert on the affected VKS tibial base plate during surgery.
The devices were distributed internationally only in Germany and Switzerland. Healthcare providers and patients should contact Smith & Nephew for further instructions regarding the return or replacement of these specific units.
The recalled product
- Product
- TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 7500272, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 24
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: B1508762
- B1504644
- B1500721
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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