Medacta GMK Hinge Tibial Insert Recalled for Missing Attachment Screw
Medacta USA Inc. is recalling one lot of GMK Hinge Tibial Inserts because they are missing a screw required for attachment to the tibial base plate.
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. The hazard is a missing component (screw) which is a defect, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Medacta USA Inc. is recalling one lot of Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO. The recall involves 4 units from Lot # 163646. The product is being recalled because the lot does not include a screw for attachment to the tibial base plate.
The affected units were distributed to California, Arizona, North Carolina, Israel, and France. The agency has classified this recall as Class II.
Healthcare providers and patients should stop using the affected product and contact Medacta USA Inc. for further instructions or a replacement.
The recalled product
- Product
- Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
- Manufacturer
- Medacta Usa Inc
- Hazard
- 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 # 163646
Distribution
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