medical Class II Updated 2019-01-23

Conformis, Inc. recalls iTotal Hip Replacement System, Total Hip Replacement System,

Recalled Product

iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101


Hazard / Issue

The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.

Issued by

FDA

Affected States: TN
Lot/Code Info: Serial Number 0424647
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →