FDA Devices recall · Reported March 14, 2018
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
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 …
Signature Orthopedics Pty Limited recalled Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral… - a moderate-severity action.
Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral… was recalled by Signature Orthopedics Pty Limited in March 14, 2018. Reason: This recall has been identified due to the batch being mislabeled, with the packaged component's size not co…. Check the official notice for the remedy. Verify recall #Z-0920-2018 with the FDA Devices before acting.
The recall
Signature Orthopedics Pty Limited issued this moderate-severity FDA Devices recall-This recall has been identified due to the batch being mislabeled, with the packaged component's size not co….
- Moderate
- severity level
- 10 units
- affected scope
- Class II
- classification
- March 14, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0920-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0920-2018 |
| Date reported | March 14, 2018 |
| Date initiated | February 2, 2018 |
| Recalling firm | Signature Orthopedics Pty Limited |
| Firm location | Sydney, N/A |
| Affected scope | 10 |
| Distribution | Worldwide Distribution - U.S. Nationwide and the country of Australia. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0920-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026