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Terminated

Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.

FDA Recall Z-1694-2021 · Posted None

Recalling FirmSignature Orthopedics Pty Limited
Recall StatusTerminated
Product CodeMEH
Date Initiated2021-04-20
Date Terminated2023-01-19
Product Quantity3 units

Reason for Recall

Product mislabeled, with the incorrect product inside the package.

Firm Action

On 04/20/21 the firm sent a letter to its consignee with the following instructions: examine your inventory and quarantine product subject to recall. In addition, if you have further distributed this product, please identify your customers and notify them at once by forwarding this letter. Please complete the Customer Acknowledgement Form.

Root Cause

Labeling mix-ups

Distribution Pattern

US Nationwide distribution in the state of NC.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121297ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULARSignature Orthopaedics Pty, Ltd. · 2012-12-28

Official Source

View FDA Recall →

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

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