Recall Z-1569-2025— Conformis Inc.
Class II · Ongoing
Class II FDA medical device recall by Conformis Inc., initiated 2025-03-25. It names one FDA 510(k) clearance: K202484. Product: restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System. Reason: 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..
- Recalling firm
- Conformis Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-03-25
- Firm location
- Wilmington, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.