Hip Implant Liner Mislabeled as Standard Instead of Hooded Design
A total of 16 acetabular liners for the Cordera Hip System were mislabeled—packaged as hooded liners but labeled as standard models. The recall affects devices from Lot 1788258 distributed in CA, FL, NV, and TN.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified by FDA as Class II, corresponding to labeling errors with potential for patient harm but without reported serious adverse outcomes. The mislabeling discrepancy—hooded liners labeled as standard—is consistent with a Moderate severity rating.
Plain-English summary
Conformis Inc. is recalling 16 acetabular liners for the restor3d Cordera Hip System (Model HDL-060-C22S-000101, Lot 1788258). The recalled units were packaged with hooded liners but incorrectly labeled as standard liners.
This mislabeling creates a functional discrepancy between the actual product and its label. In hip implant surgery, the liner design (hooded versus standard) is a critical component that affects the surgical approach and fit of the implant.
The affected liners were distributed to healthcare facilities in California, Florida, Nevada, and Tennessee. The FDA has classified this as a Class II recall.
The recalled product
- Product
- restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
- Manufacturer
- Conformis Inc.
- Hazard
- mis-labeling
- implant-mismatch
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: HDL-060-C22L-000101 UDI-DI: M572HDL060C22L011. Lot: 1788258
Distribution
Distributed nationwide across the United States.
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