Conformis recalls specific hip replacement implants 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 specific hip replacement implants that have a 3mm difference between the measurements shown in the surgical planning software and the actual implant dimensions. This discrepancy could lead to improper fit during surgery, which may cause complications for patients.
The iViews software displays neck/head lengths that differ by 3mm from the actual implant measurements. This discrepancy could cause the implant to be too long or too short for the patient's bone structure, potentially leading to improper fit during surgery.
Patients who have received the specific hip replacement implants with the listed serial numbers are affected. Those with the recalled implants are at risk of improper surgical fit.
Check the serial numbers listed in the recall notice. The affected implants have specific serial numbers starting with HBS-033-00xx-020101 and include the listed serial numbers.
Identify if your hip replacement implant has one of the listed serial numbers in the recall notice.
The recall is due to a 3mm discrepancy between the neck/head lengths displayed in the iViews software and the actual implant measurements, which could lead to improper fit during surgery.
Check if your implant's serial number matches one of the listed numbers in the recall notice.
Contact Conformis directly to determine the next steps for your specific implant.
We’ve drafted a message you can send Conformis to request your refund or repair — edit it as you like.
Subject: Recall Z-1776-2019 — Conformis Conformis Hello, I own a Conformis that is covered by recall Z-1776-2019 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.
