Stryker recalls ACM kits with breakaway femoral nozzle that may detach during surgery, risking infection or loss of function. Affected units include 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 certain ACM surgical kits because the femoral breakaway nozzle might break off during use, potentially causing infection or loss of function. This affects surgeons and hospitals using the specific lot numbers and catalog codes listed.
The breakaway femoral nozzle can disassemble or break off during use, which may cause components to fall into the surgical site. This could lead to bio-incompatibility and loss of the cement mixing system's function.
Surgeons and hospitals using the Stryker ACM system with the specific lot numbers and catalog codes are most at risk. The hazard occurs during surgical procedures when the nozzle may detach.
Check for the catalog number 0306-703-000 and lot number 23010012 on the kit. The product was sold with the GTIN 07613327051285.
Look for catalog number 0306-703-000 and lot number 23010012 on the kit packaging.
The breakaway femoral nozzle may disassemble or break off during use, potentially causing components to fall into the surgical site and leading to bio-incompatibility or loss of function.
Check the catalog number and lot number on the kit. If it matches the recalled items, contact Stryker for further instructions.
The hazard could lead to bio-incompatibility and loss of function, but the recall does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2601-2023 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2601-2023 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.
