Aesculap Vega Knee Trial Plateau Recalled for Incorrect Labeling
Aesculap is recalling 13 units of the NS357R Vega PS Tibia Trial/Preparation Plateau size T4 due to incorrect labeling. Using the wrong size could lead to implantation errors, ligament injury, pain, or revision 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 incorrect use could lead to injury or revision surgery, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Aesculap Implant Systems LLC is recalling 13 units of the NS357R Vega PS Tibia Trial/Preparation Plateau size T4. This component is part of the Vega Knee System Set #ST0468, which is used for the reconstruction of the diseased knee joint. The affected parts are located in the Vega Tibia preparation Tray (NS803) within the Vega Instrument Set (ST0468).
The recall was initiated because the product may be incorrectly labeled. If a surgeon uses the incorrectly sized trial, there is a potential risk of implanting the incorrect implant size. This error may lead to injury of ligaments, pain, and the possibility of revision surgery.
The recall covers 13 units distributed nationwide in the USA. Healthcare providers and facilities that have received these specific instruments should stop using the affected trial plateau and contact Aesculap Implant Systems LLC for instructions on how to return or replace the product.
The recalled product
- Product
- NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction of the diseased knee joint.
- Manufacturer
- Aesculap Implant Systems LLC
- Affected units
- 13
Distribution
Distributed nationwide across the United States.
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