Conformis recalls specific acetabular liner models for hip systems due to incorrect labeling. This may lead to improper use. Affected customers should contact Conformis for details.
The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
Conformis is recalling a specific acetabular liner model for hip systems because it was incorrectly labeled. This could lead to improper use if the liner is installed without knowing the correct specifications.
The hip cup liner was packaged with incorrect labeling, meaning it was labeled as a standard liner when it was actually a hooded liner. This could lead to improper installation if the surgeon does not know the correct type.
Patients who received the specific acetabular liner model HDL-060-C22L-000101 with incorrect labeling from Lot 1788258 are affected. Surgeons and medical staff who used this model are at higher risk.
Check for the model number HDL-060-C22L-000101 on the acetabular liner. The lot number 1788258 is associated with this specific incorrect labeling issue.
Reach out to Conformis directly for guidance on whether the liner is affected and next steps.
The recall is due to incorrect labeling, which could lead to improper use if the liner is installed without knowing the correct specifications. However, it is not immediately dangerous as the liner itself is not defective.
Contact Conformis directly to determine if your liner is affected and follow their instructions.
Check for the model number HDL-060-C22L-000101 and lot number 1788258 on the liner.
We’ve drafted a message you can send Conformis to request your refund or repair — edit it as you like.
Subject: Recall Z-1569-2025 — Conformis Conformis Hello, I own a Conformis that is covered by recall Z-1569-2025 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.