Signature Ceramic Femoral Head Recalled for Mislabeled Packaging
Signature Orthopedics is recalling 10 ceramic femoral heads because the packaging labels do not match the component sizes, which may cause surgical delays.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly identifies the issue as a labeling error that results in surgical delay rather than direct physical injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Signature Orthopedics Pty Limited is recalling 10 units of the Signature Ceramic Femoral Head, Model Number 111-152-621. The affected devices are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta) and are intended for use in hip replacement procedures. The specific lot number is 78560, and the UDI is 09348215001926.
The recall was initiated because the batch was mislabeled, meaning the size of the packaged component does not correspond to the information on the label. This discrepancy may result in the product intended for the procedure not being included in the packaging. Consequently, this could lead to surgical delays while replacement product is retrieved.
The affected units were distributed worldwide, including the United States and Australia. Healthcare providers and facilities that have received these specific components should verify the labeling against the physical component size and contact the recalling firm for further instructions.
The recalled product
- 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…
- Manufacturer
- Signature Orthopedics Pty Limited
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 09348215001926. Lot:78560.
Distribution
Distributed nationwide across the United States.
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