Stryker recalls ACM bone cement mixing systems with break-away femoral nozzles that may disassemble during surgery, risking bio-incompatibility. Affected units have specific catalog numbers and lot numbers.
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 its Advanced Cement Mixing (ACM) systems that use a break-away femoral nozzle. This part can break off during use, potentially causing pieces to fall into the surgical site and causing bio-incompatibility.
The break-away femoral nozzle can disassemble or break off during use. If pieces fall into the surgical site, they could cause bio-incompatibility issues, meaning the body might react to the foreign material.
Surgical teams using the Stryker ACM system with the break-away femoral nozzle are most at risk. Patients undergoing bone cement procedures with this specific model are affected.
Check for catalog number 0206-512-000 on the product label. Lot numbers 22314012 and 22336012 are also associated with this recall.
Look for catalog number 0206-512-000 and lot numbers 22314012 or 22336012.
The recall states that the break-away femoral nozzle can disassemble during use, potentially causing pieces to fall into the surgical site. This poses a risk of bio-incompatibility, so it is not safe to use without recalling.
The recall does not specify a remedy, so you should check the product label for the catalog number and lot numbers to confirm if it is affected.
Check for catalog number 0206-512-000 and lot numbers 22314012 or 22336012 on the product label.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2596-2023 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2596-2023 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.
