Stryker ACM Cement Mixing System nozzle may break during surgery
Stryker is recalling ACM Systems due to potential breakage of the femoral nozzle applicator tip during use. This could cause device failure and leave components 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 with potential for serious patient harm—loss of device function and foreign material in surgical site—but no reported illnesses or injuries. Per the rubric, theoretical hazards without incident reports score at most 3.
Plain-English summary
Stryker Corporation is recalling the ACM (Advanced Cement Mixing) System, Catalog Number 0306-573-000, used to mix bone cement during orthopedic surgery.
The Break-Away Femoral Nozzle, the applicator tip connecting the cement cartridge, may disassemble or break off during use. This could result in loss of device function and components remaining in the surgical site, creating biocompatibility concerns.
The recall affects 652 units distributed in the United States and 1,607 units distributed internationally to Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Malaysia, Poland, Singapore, South Korea, Spain, Taiwan, Thailand, and the United Kingdom. Affected lot numbers are: 22313012, 22314012, 22315012, 22343012, 22348012, 22349012, 22350012, and 22353012.
The recalled product
- Product
- Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-573-000
- Manufacturer
- Stryker Corporation
- Hazard
- component-breakoff
- device-failure
- surgical-site-contamination
Distribution
Distributed nationwide across the United States.
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