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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by 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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