Medacta Recalls GMK Knee System Inserts Due to Screw Back-Out Risk
Medacta is recalling 12,768 GMK knee system inserts nationwide due to a reported 0.1% occurrence rate of post-operative screw back-out.
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 the hazard involves a risk of harm (screw back-out) in a medical device where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Medacta USA Inc. is recalling 12,768 units of the GMK knee system, specifically the Sphere and Primary Inserts, distributed nationwide. The recall involves part number ranges 02.12.0110FL - 02.12.0620FL, 02.12.0110FR - 02.12.0620FR, and 02.07.0110PSF - 02.07.0620PSF. The FDA has classified this as a Class II recall.
The recall is initiated because Medacta observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%. The company emphasizes the importance of using the 3.5 Nm torque limiting driver if the screw is used, as directed in their surgical techniques.
Healthcare providers and patients should contact Medacta for further instructions regarding the affected devices.
The recalled product
- Product
- The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF
- Manufacturer
- Medacta Usa Inc
- Affected units
- 12,768
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)
- all serial numbers
Distribution
Distributed nationwide across the United States.
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