Stryker recalls specific ACL disposable bone-tendon-bone packs due to higher bioburden levels in some lots. This may increase infection risk during surgery. Affected units have model 0234020280 and lot number 17299AG2.
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. It is indicated to be a single surgery use, disposable set of instrumentation for anterior cruciate ligament (ACL) reconstruction surgeries.
Stryker is recalling certain ACL disposable bone-tendon-bone packs (model 0234020280) because some lots tested higher than their internal bioburden standards. This could increase infection risk during surgery if used.
The recalled packs may contain higher levels of microorganisms than the manufacturer's internal standards. Since these are single-use surgical instruments, this could increase infection risk during surgery if the product is used without proper sterilization.
Surgery patients and medical staff who use the recalled model 0234020280 packs. The risk is primarily for those undergoing ACL reconstruction surgery with this specific product.
Check for model number 0234020280 and lot number 17299AG2 on the pack. The product is labeled sterile and used for single surgery ACL reconstruction procedures.
Look for model number 0234020280 and lot number 17299AG2 on the pack label.
The recall indicates some lots have higher bioburden levels than internal standards, which could increase infection risk during surgery. Not all units are affected.
Check for model number 0234020280 and lot number 17299AG2 on the pack label.
The recall does not specify a remedy, so contact Stryker directly for guidance.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0838-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0838-2018 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.
