Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101 Recalled by Conformis, Inc. Due to Discrepancy of 3mm between the values displayed and...
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
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
Quantity: 128
Why Was This Recalled?
Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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