The Recall Desk
HighFDA (Devices)·Z-0266-2018·Announced 2017-12-27

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.

What this means for you

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
Category
Medical Device — Orthopedic Implant
Hazard
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.

Related recalls

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