Stryker recalls Synchro2 guidewires with incorrect outer diameter label (0.036mm instead of 0.36mm). This may lead to improper use during medical procedures. Affected units include specific lot numbers and product codes.
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.
Stryker is recalling certain Synchro2 guidewires that have a label error showing an incorrect outer diameter measurement (0.036mm instead of 0.36mm). This could lead to improper use during medical procedures if the wrong size is used. The recall affects specific lot numbers and product codes.
The label shows an incorrect outer diameter measurement (0.036mm) instead of the correct 0.36mm. This typographical error could lead to using the wrong size guidewire during medical procedures, potentially causing complications.
Medical professionals using the Synchro2 guidewires for neurovascular or peripheral vascular procedures are most likely affected. Patients receiving these procedures may be at risk if the incorrect size is used.
Check the product label for the outer diameter: it should read 0.014in (0.36mm). Affected units have specific lot numbers and product codes listed in the recall notice.
Verify the outer diameter measurement on the product label is 0.014in (0.36mm), not 0.036mm.
The product is safe to use if the label shows the correct outer diameter of 0.014in (0.36mm). The recall addresses a label error, not a safety issue with the product itself.
Check the label for the correct outer diameter measurement. If it shows 0.036mm instead of 0.36mm, contact Stryker for further instructions.
Check the product label for the outer diameter measurement. Affected units have specific lot numbers and product codes listed in the recall notice.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0231-2020 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0231-2020 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.
