Stryker Recalls Advanced Cement Mixing Kits Due to Sterility Concerns
Stryker is recalling 1,542 Advanced Cement Mixing Kits because bioburden levels exceeded acceptable rates, posing a sterility risk.
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 involves a medical device with a sterility defect (bioburden) which poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 1,542 units of the Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press. (Product Number: 0306-573-000). The recall is due to a lack of sterility assurance, as bioburden levels were found to be higher than internal acceptable rates.
The affected products are distributed in all 50 U.S. States and the District of Columbia, as well as in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and the United Kingdom. The specific lot numbers involved are 17282012, 17283012, 17297012, and 17298012.
Healthcare providers should stop using the affected kits and contact Stryker for further instructions. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use.
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Category
- Medical Device — Orthopedic
- Affected units
- 1,542
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 (4)
- Lot Numbers: 17282012
- 17283012
- 17297012
- 17298012 UDI: (01)4546540055415
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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