Conformis recalls hip replacement system with stage 1/2 reamer instruments that may cause bone damage due to improper fit. Affected units have specific catalog and serial numbers.
The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.
Conformis is recalling hip replacement systems where the reamer instruments have a -1mm interference fit with bone instead of the expected -2mm. This could cause bone damage during surgery.
The reamer instruments are designed to have a -2mm interference fit with acetabulum bone for proper fixation. The recalled instruments have a -1mm fit, which is too loose and may cause bone damage during surgery.
Patients who received the recalled hip replacement system with catalog number HAA-050-D001-020101 and serial number 0424647 are affected. Surgeons and medical staff using these instruments during procedures are at risk.
Check for catalog number HAA-050-D001-020101 and serial number 0424647 on the hip replacement system packaging or documentation.
Look for catalog number HAA-050-D001-020101 and serial number 0424647 on the hip replacement system packaging or documentation.
The stage 1 and 2 reamer instruments have a -1mm interference fit with bone instead of the expected -2mm, which could cause bone damage during surgery.
The recall record does not specify a remedy, so check with Conformis directly for next steps.
The recall indicates potential bone damage during surgery, but the record does not specify if this causes serious injury in normal use.
We’ve drafted a message you can send Conformis to request your refund or repair — edit it as you like.
Subject: Recall Z-0731-2019 — Conformis Conformis Hello, I own a Conformis that is covered by recall Z-0731-2019 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.
