Stryker recalls ACM kits with femoral breakaway nozzle that may break during use, causing surgical site contamination. Affected kits have specific lot numbers and catalog codes.
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 ACM surgical kits that include a breakaway femoral nozzle. If the nozzle breaks during use, it could fall into the surgical site, causing bio-incompatibility and loss of function.
The breakaway femoral nozzle can disassemble or break off during use. This may cause components to fall into the surgical site, leading to bio-incompatibility and loss of the cement mixing system's function.
Surgical teams using Stryker ACM kits with the specified lot numbers and catalog codes are most at risk. Patients undergoing bone cement procedures may be affected if the kit breaks during surgery.
Check the catalog number (0306-705-000) and GTIN (04546540055422) on the kit. Affected kits have lot numbers 22306012, 22307012, 22340012, 22341012, 22342012, or 23017012.
Verify the catalog number (0306-705-000) and GTIN (04546540055422) on the kit.
Reach out to Stryker for guidance on next steps if the kit is affected.
The breakaway femoral nozzle may disassemble or break during use, potentially causing components to fall into the surgical site and leading to bio-incompatibility.
Check for catalog number 0306-705-000, GTIN 04546540055422, and lot numbers 22306012, 22307012, 22340012, 22341012, 22342012, or 23017012.
Contact Stryker directly for guidance on next steps, as the recall does not specify a return or repair process.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2602-2023 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2602-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
