Conform: Hip screws labeled 25mm but actually 30mm may cause improper fit. Affected units: Model HAA-030-0625-000101, Lot 1232071. Contact manufacturer for details.
30mm screws were labeled as 25mm screws.
Conformis is recalling hip screws that were labeled as 25mm but are actually 30mm. This mismatch could lead to improper surgical fit and potential complications during hip replacement procedures.
The screws are labeled as 25mm but are actually 30mm in size. This size discrepancy could cause improper fit during hip replacement surgery, potentially leading to complications like improper joint alignment or instability.
Orthopedic surgeons and patients who received the specific hip screws with model number HAA-030-0625-000101 and lot number 1232071. Patients using these screws for hip replacements are most at risk.
Check for the model number HAA-030-0625-000101 and lot number 1232071 on the packaging or product label. The product is sterile and labeled as 'CONFORMIS HIP-SCREW-6.5MM X 25MM'.
Look for the model number HAA-030-0625-000101 and lot number 1232071 on the packaging or product label.
The screws are labeled as 25mm but are actually 30mm. This size mismatch could lead to improper fit during hip replacement surgery, but the recall is for identification and correction, not immediate safety risk.
Check for the model number HAA-030-0625-000101 and lot number 1232071 on the packaging or product label.
The recall does not specify a remedy, so contact Conformis directly for guidance on 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-2405-2023 — Conformis Conformis Hello, I own a Conformis that is covered by recall Z-2405-2023 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.
