Z-1694-2021Class II

Logical cup liner -

Name: Z-1694-2021 Logical cup liner -
Creator: Signature Orthopedics Pty Limited
Published: 2021-04-20
License: https://open.fda.gov/license/

Signature Orthopaedics Pty Limited / initiated 2021-04-20 / Terminated / root cause: labeling and UDI

FDA source

Signature Orthopedics Pty Limited began a recall of Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant on 2021-04-20. FDA classified it as Class II and gives the reason as "Product mislabeled, with the incorrect product inside the package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1694-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-20
Posted: 2021-05-28
Terminated: 2023-01-19
Recalling firm: Signature Orthopaedics Pty Limited
Product: Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: Product mislabeled, with the incorrect product inside the package.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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.
Quantity in commerce: 3 units
Distribution: US Nationwide distribution in the state of NC.
Product codes and lots: LOT# 71541-1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1694-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1694-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-05-28

Product code MEH

K121297Class IIOrigin Hip Stem, Femoral Head, Logical Px-Series Acetabular Shell, Locigal G-Series Acetabular Shell, Logical AcetabularSignature Orthopaedics Pty, Ltd. / cleared 2012-12-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)