Lower riskMedical device recall · FDA · Published February 2, 2018
Signature Ceramic Femoral Head Recall: Mislabeled Product Causes Surgical Delay
Signature Orthopedics recalls ceramic femoral heads (model 111-152-621) due to mislabeling causing surgical delays. Affected products may not include the intended surgical component, leading to replacement delays.
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.
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Contact the company
📍Recalling firmSignature Orthopedics Pty Limited7 Sirius Road, Lane Cove West · Sydney, Australia
“Signature Ceramic Femoral Head Recall: Mislabeled Product Causes Surgical Delay.” GovInfoNow, updated August 28, 2026. https://govinfonow.com/recall/72053-signature-ceramic-femoral-head-recall-mislabeled-product-causes-surgical-delay. Based on FDA recall #Z-0920-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0920-2018%22&limit=1).
The FDA announced on Feb. 2, 2018, that Signature Orthopedics Pty Limited voluntarily recalled its Signature Ceramic Femoral Head due to mislabeling hazards. The agency stated the recall was initiated by the firm.
How to tell if you have it
Brand: Signature Orthopedics
Product: Signature Ceramic Femoral Head
Model Number: 111-152-621
Lot Code: 78560
Quantity: 10 units
The hazard
The recall was identified because the batch was mislabeled, with the packaged component's size not corresponding to the label. This discrepancy may result in surgical delays as a replacement product is retrieved.
Context
GovInfoNow's records show Signature Orthopedics Pty Limited has two other recalls on record since Dec. 10, 2018, including a 2021-04-20 recall of the Logical Cup Liner for mislabeled products and a 2018-12-10 recall of the Genius Knee Cemented CR Femoral Component for product mix-ups. Other recent recalls of similar products include the EMPOWR 3D KNEE Implants (2026-01-15), Smith & Nephew BIOSURE HA Screw (2025-11-24), and Tornier Perip Screw (2025-12-19).
How to tell if you have this one
Check for the model number 111-152-621 on the packaging. The product was manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta) and sold with a specific lot number (78560).
Brand
Signature Orthopedics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the model number 111-152-621 on the packaging to confirm if the product is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide Distribution - U.S. Nationwide and the country of Australia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 6 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0920-2018 (February 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0920-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 28, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.