Conformis Restor3d Cordera Hip Acetabular Liner Mislabeled
Conformis is recalling certain Cordera Hip acetabular liners from Lot 1788258 due to incorrect labeling. Units labeled as standard liners actually contain hooded liners, creating a mismatch between the label and the product.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with a labeling/identification error that could result in incorrect surgical implantation. While no adverse health effects or injuries are reported in the source, the potential for harm exists if the mislabeled liner is implanted incorrectly, meeting the High severity threshold for risk-of-harm medical devices.
Plain-English summary
Conformis Inc. is recalling the restor3d Cordera Hip System acetabular liners (Model Number HDL-060-C22S-000101) from Lot 1788258 due to labeling discrepancy. These hip cup liners were packaged with incorrect labeling that identified them as standard liners when they actually contained hooded liners.
This mislabeling creates a mismatch between what the label indicates and what is in the package, which could lead to incorrect surgical implantation if not caught before use.
The affected product was distributed nationwide in California, Florida, Nevada, and Tennessee. A total of 16 units are involved in this recall.
Patients or healthcare providers who believe they may have received one of these affected liners should contact Conformis Inc. immediately for instructions on how to proceed.
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.
- Affected units
- 16
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
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