Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
iTotal Hip Replacement System Recalled by Conformis, Inc. Due to The stage 1 and 2 reamer instruments used...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Conformis, Inc. directly.
Affected Products
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Quantity: 1
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 1 state: TN
About Conformis, Inc.
Conformis, Inc. has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report