restor3d Cordera Hip System. ACETABULAR LINER GRP C recall: Labeling Error
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
Why was restor3d Cordera Hip System. ACETABULAR LINER GRP C 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: HDL-060-C22L-000101 UDI-DI: M572HDL060C22L011. Lot: 1788258
- Product
- restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
- Recalling firm
- Conformis Inc.
- Quantity
- 16
- Distribution
- US Nationwide distribution in the states of CA, FL, NV, TN.
- Recall date
- April 23, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)