Conformis recalls specific hip replacement stems due to 3mm discrepancy between iViews measurements and actual implant neck/head lengths, potentially causing improper fit.
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.
Conformis is recalling certain hip replacement stems (HBS-033-00xx-010101) because the measured neck/head lengths in the implants differ by 3mm from what surgeons approved. This could lead to improper fit during surgery, risking complications.
The implants have a 3mm discrepancy between the values displayed in the iViews surgical planning software and the actual neck/head lengths of the manufactured stems. This mismatch could cause improper fit during surgery, potentially leading to complications like improper alignment or instability of the hip joint.
Patients who received the specific hip replacement stems listed in the recall (serial numbers starting with 422796-442816) are affected. Surgeons who used these stems during hip replacement procedures are most at risk.
Check if your hip replacement stem has a serial number listed in the recall (e.g., 422796, 424450, 425346, 429552, 431199, 435657, 437425, 442745). The product is labeled as 'HIP-PATIENT SPECIFIC STEM LEFT' and includes specific model numbers (HBS-033-00xx-010101).
Look for the serial number on your hip replacement stem to see if it matches any of the listed numbers in the recall.
Reach out to Conformis directly to confirm if your stem is affected and get instructions for next steps.
The recall occurs because the neck/head lengths in the manufactured implants differ by 3mm from what surgeons approved using iViews software, which could cause improper fit during surgery.
Check if your stem's serial number appears in the list provided in the recall (e.g., 422796, 424450, 425346, 429552, 431199, 435657, 437425, 442745).
Contact Conformis directly to confirm if your stem is affected and get instructions for next steps.
We’ve drafted a message you can send Conformis to request your refund or repair — edit it as you like.
Subject: Recall Z-1775-2019 — Conformis Conformis Hello, I own a Conformis that is covered by recall Z-1775-2019 from Conformis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
