Agency classClass IIOur severity:High FDA (Devices)·Z-1547-2016·Announced 2016-04-27

Smith & Nephew Recalls TC-PLUS Tibial 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 seating of the polyethylene insert 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 involves a high-risk medical device where a manufacturing defect could prevent proper surgical implantation, representing a risk of harm even though no specific injuries 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 4 Right, Sterile R, Reference 12 000 024, Serial Number 7500279. The affected devices are tibial knee prostheses manufactured by Smith & Nephew Orthopaedics AG.

The recall is due to a potential dimensional deviation in the affected devices. 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 affected units were distributed internationally only in Germany and Switzerland.

The affected batch numbers are B1512224, B1509601, B1506853, B1501435, and B1500308. Healthcare providers and patients should contact Smith & Nephew for further instructions regarding the recall and replacement of these devices.

The recalled product

Product: TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE R, REF 12 000 024, S&N 7500279, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Manufacturer: Smith & Nephew, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: manufacturing-defect
surgical-complication
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 (5)

Batch numbers: B1512224
B1509601
B1506853
B1501435
B1500308

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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