Conformis recalls iTotal Hip Replacement System Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right due to two femoral stems being switched in packaging. Affected patients should contact the manufacturer for details.
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
Conformis is recalling a specific hip replacement stem model because it was mistakenly packed with the wrong size stem. This could lead to improper fitting during surgery if the wrong stem is used.
The stems were switched in packaging, meaning a Size 13 stem might be sent to a patient who needs a Size 15 stem. This could cause improper fitting during surgery, potentially leading to complications.
Patients who received this specific hip replacement stem model (Size 13 Hip-Patient Specific Stem Right) are affected. Surgeons and medical staff who used this model during procedures are at higher risk.
Check for the model number HBS-033-0013-020101 on the packaging or label of the hip replacement stem. The product was sold with the part number 0447621.
Reach out to Conformis Inc. for guidance on whether the stem is affected and next steps.
The recall is for a packaging error that could lead to improper fitting during surgery if the wrong stem is used. It is not an immediate safety hazard for patients already implanted.
Look for the model number HBS-033-0013-020101 on the packaging or label of the hip replacement stem. The product was sold with part number 0447621.
Contact Conformis Inc. to determine if your stem is affected and follow their instructions.
We’ve drafted a message you can send Conformis to request your refund or repair — edit it as you like.
Subject: Recall Z-0064-2020 — Conformis Conformis Hello, I own a Conformis that is covered by recall Z-0064-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
