Stryker AutoPlex Bone Cement Recalled for Sterility Assurance Issues
Stryker is recalling AutoPlex bone cement systems because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of sterility assurance in a medical device, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling the AutoPlex System and AutoPlex System with VertaPlex HV bone cement products. The recall was initiated because bioburden levels were found to be higher than internal acceptable rates, indicating a lack of sterility assurance.
The affected products include the AutoPlex System (Product Number: 0605-887-000) and the AutoPlex System with VertaPlex HV (Product Number: 0607-687-000). A total of 1,244 units were distributed in all 50 U.S. states, the District of Columbia, and several international countries including Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, the Netherlands, and the United Kingdom.
Specific lot numbers affected include 17278012, 17278022, 17279022, 17282012, 17282022, 17291012, and 17291022. Healthcare providers and facilities should stop using these products and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 1,244
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 (9)
- 1. Lot Number: 17278012
- 2. Lot Numbers: 17278012
- 17278022
- 17279022
- 17282012
- 17282022
- 17291012
- 17291022 UDI: (01)4546540593108
- (01)7613252039259
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 13 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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