Stryker DirectInject Bone Cement Recalled Due to Injection Failure
Stryker is recalling 321 units of DirectInject bone cement because the paste cannot be injected from the syringe into the target location.
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 hazard is a functional failure (inability to inject) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Leibinger GmbH & Co. KG is recalling 321 units of DirectInject, a sterile dual paste system used to form a moldable cement paste that hardens into hydroxyapatite. The recall is due to a defect that prevents the user from injecting the paste from the syringe into the target location.
The affected product is distributed worldwide, including in the United States, Germany, Italy, France, Australia, and Japan. The specific lot numbers are DI20311 and DI20307, and the product code is 07613327123265.
Healthcare providers and patients should stop using the affected units and contact Stryker for further instructions.
The recalled product
- Product
- DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.
- Manufacturer
- Stryker Leibinger GmbH & Co. KG
- Category
- Medical Device — Bone Cement
- Hazard
- Affected units
- 321
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 (2)
- Lot: DI20311
- DI20307 Product Code (UDI): 07613327123265
Distribution
Distributed nationwide across the United States.
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