Stryker recalls Surgistool Model 830 for home use. Healthcare devices distributed to residential customers may cause injury if used incorrectly without professional training.
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
Stryker is recalling Surgistool Model 830 devices that were mistakenly sold to home users instead of healthcare facilities. These tools are designed for professional surgical use and could cause injury if someone without proper training attempts to use them at home.
These surgical tools are designed for healthcare professionals in clinical settings. Home users may not understand the correct procedures or risks, potentially causing injury during use.
Home users who purchased this surgical tool without professional training are at risk. Healthcare professionals using it in facilities are not affected by this recall.
Check for the model number 830 and part number 0830000000 on the device. Serial numbers include 1202033898, 1206032470, 1406034563, or 1607037109. The UDI (DI#) is 07613327282566.
Look for model number 830 and part number 0830000000 on the device.
Reach out to Stryker for guidance on whether to keep or return the device.
No, this surgical tool is designed for healthcare professionals in clinical settings only. Home users may not understand the correct procedures and could be at risk.
Check for model number 830 and part number 0830000000. Serial numbers include 1202033898, 1206032470, 1406034563, or 1607037109.
Contact Stryker for guidance on whether to keep or return the device. The recall does not require immediate action but requires professional consultation.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2206-2021 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2206-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
