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
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