Signature Orthopaedics Recalls Mislabeled Encina HA Femoral Stem Components
Signature Orthopaedics is recalling five mislabeled Encina HA Femoral Stem components. The packaging error could cause surgical delays if the wrong product is used.
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 indicates the primary risk is a surgical delay due to mislabeling rather than direct physical injury or death, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Signature Orthopaedics Europe Ltd is recalling five components of the Encina HA Femoral Stem, Size 11 Coxa Vara Collared (REF 100-30-011). These components are made of Ti6AI4V Alloy with HA Coating and are intended for use with the Stinson Orthopedics Inc. Total Hip Replacement System only. The specific lot number is 7DD49-1.
The recall was initiated because the packaging for these components is mislabeled. This labeling error could result in a product intended for a different procedure being used, which may lead to a surgical delay. The affected components were distributed in California.
Healthcare providers and patients who have received or used these specific components should contact Signature Orthopaedics Europe Ltd for further instructions. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc. Total Hip Replacement System Only, CEMENTLESS, UDI: (01) 00841176102934
- Manufacturer
- Signature Orthopaedics Europe Ltd
- Affected units
- 5
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)
- Lot # 7DD49-1
Distribution
Distributed in 1 state:
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