Stryker Corporation 2023-09-27 Health serious FDA
Health · FDA · Recall #FDA-Z-2598-2023
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows… Recall
Issued September 27, 2023 · Stryker Corporation
In September 2023, Stryker Corporation recalled the Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site
What you should do
- 1 Stop using Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Stryker Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Stryker Corporation
- Category
- Health
- Recall date
- September 27, 2023
- Units affected
- Not reported
- Sold at
- Nationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy Malaysia Poland Singapore South Korea Spain Taiwan Thailand UK
- Recall number
- FDA-Z-2598-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Stryker Corporation has 15 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.