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 Two femoral stems, sizes 13 and 15, were...
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, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
Quantity: 1
Why Was This Recalled?
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
Where Was This Sold?
This product was distributed to 2 states: MD, NV
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