Stryker recalls Synchro2 guidewires with incorrect outer diameter label (0.036mm instead of 0.014in). This could lead to improper use in medical procedures. Affected units include specific lot numbers.
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 due to a label error showing an incorrect outer diameter measurement. This could lead to improper use during medical procedures if the wrong size is used. The recall affects specific lot numbers and model types.
The label shows an incorrect outer diameter measurement (0.036mm) instead of the correct 0.014in (0.36mm). This typographical error could lead to using the wrong size guidewire during procedures, potentially causing complications.
Healthcare professionals using the Synchro2 guidewires for medical procedures are most at risk. The recall applies to specific lot numbers and model types sold in the U.S.
Check the product label for the outer diameter dimension. The affected guidewires have a label showing 0.036mm instead of 0.014in (0.36mm). Specific lot numbers include 0000001911 and 0000002062.
Verify the outer diameter dimension on the product label matches 0.014in (0.36mm) instead of 0.036mm.
The product is safe to use if the label shows the correct outer diameter of 0.014in (0.36mm). The error is a typographical mistake that does not affect safety in normal use.
Check the label for the outer diameter dimension. If it shows 0.036mm instead of 0.014in (0.36mm), contact Stryker for verification.
Lot numbers 0000001911 and 0000002062 are affected.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0228-2020 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0228-2020 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.
