Stryker bone cement cartridge nozzles may disassemble during surgical use
Stryker is recalling bone cement cartridges because the breakaway femoral nozzle applicator tip may disassemble or break off during use, potentially causing loss of device function and foreign material in the surgical site.
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: FDA Class II device recall with potential for serious harm in surgical setting (foreign body in operative field) but no reported illnesses or injuries. This constitutes a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Stryker Corporation is recalling its ACM (Advanced Cement Mixing) 180-Gram Cement Cartridge with Breakaway Femoral Nozzle due to a potential defect in the applicator tip.
The Break-Away Femoral Nozzle can disassemble or break off during use. If this occurs, it can result in loss of function of the ACM system and risk bio-incompatibility due to components falling into the surgical site during bone cement application.
The recall affects 224 units distributed in the United States and 718 units distributed internationally, including Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Malaysia, Poland, Singapore, South Korea, Spain, Taiwan, Thailand, and the United Kingdom. Affected lot numbers are 22332012, 22336012, 22333012, 22355012, and 23052012.
Healthcare facilities and surgical teams should contact Stryker Corporation or consult FDA guidance regarding this recall.
The recalled product
- Product
- Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0206-530-000
- Manufacturer
- Stryker Corporation
- Hazard
- device-malfunction
- foreign-body-risk
- bio-incompatibility
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 (1)
- GTIN: 04546540857880 Lot Numbers: 22332012 22336012 22333012 22355012 23052012
Distribution
Distributed nationwide across the United States.
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