Stryker recalls certain ACL Interface Screws (Model 0234010056) due to higher bioburden levels in some lots. Affected items may pose infection risks during surgery.
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Stryker is recalling specific ACL Interface Screws (Model 0234010056) because some batches had higher bioburden levels than expected. This could increase infection risk during surgical procedures.
Bioburden refers to bacteria levels in medical devices. Higher than expected bacteria in some screw batches could lead to surgical site infections if used improperly.
Surgical teams using the recalled screws for ACL repairs are most at risk. Patients undergoing surgery with these screws may face higher infection chances.
Check for the model number 0234010056 on the screw packaging. The lot number 17278AG2 is also associated with this recall.
Verify the model number 0234010056 and lot number 17278AG2 on the screw packaging.
The recall is for higher bioburden levels in some screw batches, which could increase infection risk during surgery. However, the hazard level is low risk as the remedy focuses on checking and not immediate action.
Look for the model number 0234010056 and lot number 17278AG2 on the screw packaging.
The recall does not specify a remedy, so check the product details and contact Stryker if you have concerns.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0837-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0837-2018 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.
