Signature Ceramic Femoral Head — Class II medical device recall Z-0920-2018
Terminated recall by Signature Orthopedics Pty Limited, reported 2018-03-14, distributed nationwide. This recall has been identified due to the batch being mislabeled, with the packaged component's size not corr
| Recall number | Z-0920-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Signature Orthopedics Pty Limited, Sydney, N/A, Australia |
| Recall initiated | 2018-02-02 |
| Classified | 2018-03-06 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2018-08-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 10 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 09348215001926 |
| Lot numbers | 78560 |
| Model numbers | 111-152-621 |
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
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.
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-0920-2018. 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.