Trilliant Surgical recalls outdated instructions for use and cleaning protocols for 3S Hemi Toe Implant. Updated documents may affect surgical safety if not followed correctly.
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
Trilliant Surgical is recalling outdated instructions for use and cleaning protocols for their 3S Hemi Toe Implant. This recall happened in 2018 because older versions of these documents could lead to improper sterilization during surgery.
The recall involves outdated instructions for use and cleaning protocols that were in effect before 2018. If these older documents are used, there's a risk of improper sterilization during surgery, which could lead to infection or other complications.
Surgical teams using the 3S Hemi Toe Implant before 2018 may be affected. Patients undergoing surgery with this implant are at low risk if the outdated instructions are not followed.
Check for the product label showing 'Trilliant Surgical Ltd' and the model number 111-00-001. The recall applies to instructions and protocols issued before Document #900-01-009 Rev. I and Document #900-06-008 Rev. H from 2018.
Check if your instructions and cleaning protocols are from versions older than Document #900-01-009 Rev. I and Document #900-06-008 Rev. H.
The recall occurred in 2018 because older versions of the Instructions for Use and Cleaning and Sterilization Protocols could lead to improper sterilization during surgery.
Check if your instructions and protocols are older than Document #900-01-009 Rev. I and Document #900-06-008 Rev. H from 2018. If so, review the updated documents.
The recall indicates a low risk as outdated instructions could lead to improper sterilization, but serious injury is not explicitly stated as a hazard.
We’ve drafted a message you can send Trilliant Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1611-2020 — Trilliant Surgical Trilliant Surgical Hello, I own a Trilliant Surgical that is covered by recall Z-1611-2020 from Trilliant Surgical. 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.
