Logical cup liner — Class II medical device recall Z-1694-2021
Terminated recall by Signature Orthopedics Pty Limited, reported 2021-06-09, distributed nationwide. Product mislabeled, with the incorrect product inside the package.
| Recall number | Z-1694-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Signature Orthopedics Pty Limited, Lane Cove West, Australia |
| Recall initiated | 2021-04-20 |
| Classified | 2021-05-28 |
| Reported by FDA | 2021-06-09 |
| Terminated | 2023-01-19 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| Reason classes | labeling |
| Lot numbers | 71541-1 |
Product
Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.
Reason for recall
Product mislabeled, with the incorrect product inside the package.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1694-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.