Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System

FDA Recall Z-1569-2025 · Posted 2025-04-15

Recalling FirmConformis Inc.
Recall StatusOpen, Classified
Product CodeLPH
Date Initiated2025-03-25
Product Quantity16

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.

Firm Action

On about 03/25/2025, Conformis notified consignees via email with letter titled "URGENT: MEDICAL DEVICE RECALL." Consignees were instructed to examine inventory, quarantine any affected units on hand, and make arrangements to return the product. Additionally, consignees were asked to complete and return the response portion of the letter.

Root Cause

Labeling Change Control

Distribution Pattern

US Nationwide distribution in the states of CA, FL, NV, TN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K202484Cordera Hip SystemConformis, Inc. · 2020-09-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑