Medacta Recalls GMK Hinge Knee Prosthesis Due to Incorrect Screws
Medacta USA is recalling 4 units of GMK Hinge knee prostheses because they contain 5 mm screws instead of the required 10 mm screws.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The defect involves incorrect hardware size, which is a significant quality issue but does not explicitly report injuries or deaths in the source text, fitting the Moderate category for a precautionary recall of a medical device with a specific manufacturing error.
Plain-English summary
Medacta USA is recalling 4 units of the GMK Hinge knee prosthesis, Model Number 02.09.TA410, manufactured in the United States. The recall is due to a manufacturing error where packages of the GMK Hinge Tibial Augmentation size 4-10 mm were shipped with 5 mm screws instead of the correct 10 mm screws.
The affected units were distributed in the states of Illinois, Ohio, and Utah, as well as in Austria, Spain, Australia, France, and Switzerland. The specific lot number for the recalled items is 145129.
Consumers and healthcare providers who have purchased or received these specific units should stop using them and contact Medacta USA for further instructions on how to return or replace the product.
The recalled product
- Product
- GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
- Manufacturer
- Medacta Usa
- Affected units
- 4
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)
- Lot: 145129
Distribution
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