Stryker recalls heavy duty sagittal blades (catalog 6125-127-100) due to potential sterility breach during manufacturing. Affected units may not be sterile, risking infection during surgery.
During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.
Stryker is recalling heavy duty sagittal blades that could have been improperly packaged during manufacturing, potentially compromising sterility. This risk could lead to surgical infections if the blades are used without proper sterility.
During manufacturing, some blades may have had packaging materials improperly positioned, creating a potential breach in sterility. If the blades are used without proper sterility, they could introduce infection during surgery.
Surgeons using Stryker Heavy Duty Sagittal Blades for orthopedic procedures are affected. Those with the specific catalog number 6125-127-100 and serial number 18247037 are most at risk.
Check for catalog number 6125-127-100 and serial number 18247037 on the blade packaging. These blades are used in orthopedic surgeries for bone cutting and shaping.
Verify if the blade has a valid sterility indicator or packaging integrity before use.
During manufacturing, some blades may have had packaging materials improperly positioned, potentially breaching sterility.
Catalog number 6125-127-100 with serial number 18247037.
The recall does not require immediate discontinuation; check sterility status before use.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1215-2019 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1215-2019 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.
