The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1540-2016·Announced 2016-04-27

Smith & Nephew Recalls TC-Plus Knee Prosthesis Due to Dimensional Deviation

Smith & Nephew is recalling one unit of a TC-Plus knee prosthesis due to a dimensional deviation that may prevent the polyethylene insert from seating correctly during surgery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 where the hazard is a potential surgical complication (inability to seat the insert) without reported injuries or illnesses.

Plain-English summary

Smith & Nephew, Inc. is recalling one unit of the TC-Plus Primary Fixed Tibial Component VKS Right, Size 2 Right, Sterile R, Reference 12 000 009, Serial Number 7500264. The device is a tibial knee prosthesis manufactured by Smith & Nephew Orthopaedics AG.

The recall is due to a dimensional deviation in the affected device that could potentially result in the surgeon being unable to seat the polyethylene insert on the VKS tibial base plate during surgery. The agency has classified this recall as Class II.

The affected device was distributed internationally only in Germany and Switzerland. No specific consumer actions are detailed in the provided source text beyond the recall notification.

The recalled product

Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE R, REF 12 000 009, S&N 7500264, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
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 C1507853

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.

See all 15 products in this recall →

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