Stryker Recalls 180-Gram Cement Cartridges Due to Sterility Assurance Issues
Stryker is recalling 708 units of 180-Gram Cement Cartridges with Breakaway Femoral Nozzles because bioburden levels were found to be higher than internal acceptable rates.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of sterility assurance in a medical device, which poses a significant risk of infection or injury, meeting the criteria for a Severe rating.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 708 units of 180-Gram Cement Cartridges with Breakaway Femoral Nozzles, Product Number 0206-530-000. The recall affects Lot Numbers 17277012 and 17283012, identified by UDI (01)4546540857880. These products are intended for orthopedic use.
The recall was initiated due to a lack of sterility assurance, as bioburden levels were found to be higher than internal acceptable rates. The agency has classified this as a Class II recall.
The affected products were 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, the Netherlands, and the United Kingdom. Healthcare providers and facilities should stop using the affected lots and contact Stryker for further instructions.
The recalled product
- Product
- 180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for orthopedic use.
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 708
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 Numbers: 17277012
- 17283012 UDI: (01)4546540857880
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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