Z-0920-2018Class II

Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are...

Name: Z-0920-2018 Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are...
Creator: Signature Orthopedics Pty Limited
Published: 2018-02-02
License: https://open.fda.gov/license/

Signature Orthopaedics Pty Limited / initiated 2018-02-02 / Terminated / root cause: labeling and UDI

FDA source

Signature Orthopedics Pty Limited began a recall of Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3... on 2018-02-02. FDA classified it as Class II and gives the reason as "This recall has been identified due to the batch being mislabeled, with the packaged component's size not corresponding to the label. Therefore, the product intended to be used for the procedure may not be included in...". 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-0920-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-02
Posted: 2018-03-06
Terminated: 2018-08-08
Recalling firm: Signature Orthopaedics Pty Limited
Product: Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within the Logical Acetabular Cups. Product Usage: Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis Inflammatory joint disease including rheumatoid arthritis Correction of functional deformity including congenital hip dysplasia Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: This recall has been identified due to the batch being mislabeled, with the packaged component's size not corresponding to the label. Therefore, the product intended to be used for the procedure may not be included in the packaging resulting in surgical delay as replacement product is retrieved.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Signature Orthopaedics notified customer(s) of the recall by sending an Urgent Medical Device Recall Letter dated February 2, 2018 via email. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Customer Acknowledgement Form and firm's Effectiveness Check Questionnaire.
Quantity in commerce: 10
Distribution: Worldwide Distribution - U.S. Nationwide and the country of Australia.
Product codes and lots: UDI: 09348215001926. Lot:78560.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0920-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0920-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-06

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)