Stryker AutoPlex System Recalled Due to Piston Head Separation Risk
Stryker is recalling AutoPlex System kits because the piston head may separate, blocking the valve and causing cement backflow toward the injector handle.
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 describes a potential delay in surgery and mechanical malfunction without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm has not been reported.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling the Stryker AutoPlex System, a medical device used for bone cement. The recall affects Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. The kits contain a cement mixer, cement injector, funnel, and an extension tube assembly used to mix and dispense bone cement directly into a fracture site.
The recall is being conducted because the Piston Head can become separated from the Delivery Piston. This separation can block the injection assembly Valve, resulting in a cement backflow towards the injector handle. This defect may lead to a delay in surgery if additional cement needs to be prepared for the injection procedure.
The affected products were distributed worldwide, including in the US, France, Netherlands, Spain, Italy, Canada, Israel, Romania, Switzerland, and the United Kingdom. A total of 4,841 boxes (9,682 units) are involved. Healthcare facilities should stop using the affected devices and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. For bone cement. Stryker AutoPlex System kits contain a cement mixer, cement injector, funnel, and an extension tube assembly whereby bone cement powder and liquid monomer…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
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 (20)
- 16027022
- 16049012
- 16061012
- 16092012
- 16107012
- 16022012
- 16028012
- 16049022
- 16063012
- 16098012
- 16109012
- 16025012
- 16028022
- 16049032
- 16063022
- 16100012
- 16109022
- 16025022
- 16033012
- 16053012
Distribution
Distributed nationwide across the United States.
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