FDA-Device2019-01-23Class II
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Conformis, Inc.
Hazard
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.
Sold states
The products were distributed to the following US states: TN.
Affected count
1
Manufactured in
600 Technology Park Dr, Billerica, MA, United States
Products
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0731-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief