Conformis Inc. recalls restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22…

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.

On about 03/25/2025, Conformis notified consignees via email with letter titled "URGENT: MEDICAL DEVICE RECALL." Consignees were instructed to examine inventory, quarantine any affected units on hand, and make arrangements to return the product. Additionally, consignees were asked to complete and return the response portion of the letter.

• FDA enforcement recordOfficial FDA database entry for Z-1569-2025
• FDA 510(k) clearance · K202484The device's official FDA premarket clearance record
• FDA device classification · LPHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3358The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Conformis Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.