restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
Reported: April 23, 2025 Initiated: March 25, 2025 #Z-1569-2025
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.
Details
- Recalling Firm
- Conformis Inc.
- Units Affected
- 16
- Distribution
- US Nationwide distribution in the states of CA, FL, NV, TN.
- Location
- Wilmington, MA
Frequently Asked Questions
What product was recalled? ▼
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System. Recalled by Conformis Inc.. Units affected: 16.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 23, 2025. Severity: Moderate. Recall number: Z-1569-2025.
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