restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for
Summary
The FDA issued a Class II for restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL- by Conformis Inc.. 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 .
Details
Source
Device Recall
External ID
Z-1569-2025
Action Date
2025-04-23
Status
Ongoing
Category
device
Product Description
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
Lot/Code Info: Model Number: HDL-060-C22L-000101 UDI-DI: M572HDL060C22L011. Lot: 1788258
Quantity Affected: 16
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.
Distribution
US Nationwide distribution in the states of CA, FL, NV, TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-25
Company
Wilmington, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Conformis Inc. has 16 FDA actions in our database, including 5 recalls and 11 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Conformis Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Conformis Inc. have FDA actions?
Conformis Inc. has 16 FDA actions in our database, including 5 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1569-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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