Stryker recalls 2.3mm Tapered Router (Catalog 5820-071-023) used in craniotomy due to potential core diameter undersizing that may cause router breakage and metal fragments in surgical site.
There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures.
Stryker is recalling a specific 2.3mm Tapered Router used in brain surgery because it might break during procedures, risking metal fragments in the surgical area. This could require additional surgery or damage critical brain structures.
The router's core diameter might be too small, causing it to break during use. If it breaks, metal fragments could enter the surgical site, potentially requiring additional surgery or damaging brain tissue and blood vessels.
Surgical teams using this specific router during craniotomy procedures are most at risk. Patients undergoing brain surgery with this instrument may face complications.
Check for the catalog number 5820-071-023 on the router. Affected lots include 22011017, 21330017, 20216017, 20140017, and 20139027.
Look for the affected lot numbers: 22011017, 21330017, 20216017, 20140017, or 20139027.
The recall states there is a potential for the router to break during use, which could cause metal fragments in the surgical site. Do not use this specific model until the recall is addressed.
Check the lot number against the affected lots listed. If it matches, stop using it and contact Stryker for further instructions.
The recall indicates a potential risk of breakage, so do not use this specific model until the manufacturer provides a solution.
We’ve drafted a message you can send Stryker Instruments to request your refund or repair — edit it as you like.
Subject: Recall Z-1478-2022 — Stryker Instruments Stryker Instruments Hello, I own a Stryker Instruments that is covered by recall Z-1478-2022 from Stryker Instruments. 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.
