FDAApril 7, 2022device
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 recall recorded by the U.S. Food & Drug Administration.
The hazard
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
What to do
FDA enforcement status: Ongoing
Brands named
synthes usa productssynthessynthes usa
UPCs
108869823008291088698230061410886982300621108869823006381088698230064510886982300652108869823006691088698230067610886982300683108869823006901088698230070610886982300713
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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