Stryker recalls ACM bone cement kits with a breakaway femoral nozzle that may disassemble during use, risking surgical site contamination. Affected units include specific lot numbers from 2022-2023.
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 bone cement mixing systems that may break during surgery, potentially causing harmful fragments to enter the surgical site. This poses a serious risk to patients during orthopedic procedures.
The breakaway femoral nozzle can detach during cement mixing, leading to pieces falling into the surgical site. This may cause bio-incompatibility and compromise the procedure's safety.
Orthopedic surgeons and medical facilities using the recalled Stryker ACM bone cement kits. Patients undergoing joint surgery are at risk if the faulty nozzle breaks during the procedure.
Check for the Stryker ACM kit with lot numbers listed in the recall (e.g., 22305012, 22306012). The product allows mixing bone cement with high vacuum.
Discontinue use of the recalled Stryker ACM bone cement system with the breakaway femoral nozzle to prevent potential surgical site contamination.
The breakaway femoral nozzle may disassemble during use, risking fragments entering the surgical site and causing bio-incompatibility.
Lot numbers 22305012 through 23019012 as listed in the recall notice.
The recall does not specify a fix; the remedy is null, meaning users must stop using the product immediately.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2598-2023 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2598-2023 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.
