Stryker recalls ACM kits with breakaway femoral nozzles due to risk of components falling into surgical sites. Affected units include specific lot numbers from 2022. Contact Stryker for replacement.
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
Stryker is recalling certain ACM surgical kits because the breakaway femoral nozzle might detach during use, potentially causing harmful fragments to enter the surgical site. This poses a risk of infection or complications for patients undergoing bone cement procedures.
The breakaway femoral nozzle may detach during use, causing small components to fall into the surgical site. This could lead to bio-incompatibility, infection, or other complications for the patient.
Surgical teams using Stryker's ACM kits with the breakaway femoral nozzle are most at risk. Patients undergoing bone cement procedures with these kits could face complications if the nozzle detaches.
Check for the catalog number 0306-573-000 or GTIN 04546540055415 on the kit. Affected units include specific lot numbers from 2022: 22313012 through 22353012.
Look for lot numbers 22313012 through 22353012 on the product label.
Reach out to Stryker Corporation for a replacement kit or further instructions.
The breakaway femoral nozzle may detach during use, potentially causing components to fall into the surgical site and cause bio-incompatibility or infection.
The affected kits have catalog number 0306-573-000 and lot numbers 22313012 through 22353012.
Contact Stryker Corporation directly for a replacement kit or further instructions.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2600-2023 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2600-2023 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
