Medacta Usa Inc recalls Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
- Recall date
- May 19, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2661-2017
- FDA classification
- Class II
- Brand / firm
- Medacta Usa Inc
- Sold / distributed
- CA, AZ, NC, Israel, France
Why it was recalled
One lot of product does not include a screw for attachment to the tibial base plate.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
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