Stryker recalls 180g cement cartridges with breakaway femoral nozzles due to potential disassembly during use, risking surgical site contamination. Affected units include specific lot numbers from 2012.
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 180-gram cement cartridges used in bone cement mixing procedures. The breakaway femoral nozzle may detach during use, potentially causing surgical site contamination if components fall into the wound.
The breakaway femoral nozzle may disassemble or break off during use, leading to components falling into the surgical site. This could cause bio-incompatibility issues and loss of function for the bone cement mixing system.
Surgical professionals using Stryker's ACM bone cement mixing system with the specified lot numbers are most at risk. Patients undergoing procedures with these cartridges could face complications from contaminated surgical sites.
Check the lot numbers on the cartridge: 22332012, 22336012, 22333012, 22355012, or 23052012. The product is a 180-gram cement cartridge with a breakaway femoral nozzle for bone cement mixing.
Verify the lot number on the cartridge to see if it matches the affected numbers: 22332012, 22336012, 22333012, 22355012, or 23052012.
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.
Check the lot number on the cartridge to see if it matches the affected numbers: 22332012, 22336012, 22333012, 22355012, or 23052012. If it does, stop using it and contact Stryker for guidance.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2597-2023 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2597-2023 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.
