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Synthes (USA) Products LLC recalls Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in
Recalled May 18, 2022 · FDA recall Z-1072-2022 · Synthes (USA) Products
Hazard
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis. · FDA Class II
Units
N/A
Sold at
US Nationwide distribution.
Description
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
Product
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.
Manufacturer(s)
Synthes (USA) Products LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →