Stryker Recalls Femoral Canal Pressurizers Due to Sterility Assurance Issues
Stryker is recalling specific lots of Femoral Canal Pressurizers 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 involves a medical device with a lack of sterility assurance (bioburden issues), which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 444 units of Femoral Canal Pressurizers without Hub, in Medium (Blue) and Large (Red) sizes, for orthopedic use. The recall involves specific lot numbers 17276012 (Medium) and 17282012 (Large).
The recall was initiated because bioburden levels were found to be higher than internal acceptable rates, indicating a lack of sterility assurance. The products 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, Netherlands, and the United Kingdom.
Healthcare providers and facilities should check their inventory for these specific product numbers and lot numbers. If the products are found, they should be removed from use and returned to Stryker according to the company's instructions.
The recalled product
- Product
- 1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hub, Large, Red, Product Number: 0206-547-000, UDI: (01)4546540039569 for orthopedic use.
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 444
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 (3)
- Lot Number (Medium): 17276012
- Lot Number (Large): 17282012 UDI: (01)4546540039552
- (01)4546540039569
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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