FDA-Device2022-05-18Class II
Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm in length.
Synthes (USA) Products LLC
Hazard
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
Sold states
US Nationwide distribution.
Affected count
N/A
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm in length.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1072-2022Don't want to check this manually?
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