Trilliant Surgical recalls instructions for use and sterilization protocols for Small Joint Reaming System Model 311-00-001 due to updated dry time parameters in 2018. Affected units have older IFUs and cleaning protocols.
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 the Instructions for Use and Sterilization Protocols for their Small Joint Reaming System Model 311-00-001 because the old versions had different dry time parameters. This update was made in 2018 to address potential safety issues with the cleaning process.
The recall involves updated dry time parameters in the cleaning and sterilization process. Older versions of the instructions might not have specified the correct drying time, potentially leading to improper sterilization or contamination risks during surgical procedures.
Surgical professionals who use the Small Joint Reaming System Model 311-00-001 with older Instructions for Use or Sterilization Protocols are affected. Those who have the product with IFUs before Document #900-01-012 Rev. F or Cleaning Protocols before Document #900-06-011 Rev. E are most at risk.
Check if your Small Joint Reaming System has Instructions for Use (IFU) versions before Document #900-01-012 Rev. F or Cleaning and Sterilization Protocols before Document #900-06-011 Rev. E. The product was sold starting in 2018.
Verify if your Small Joint Reaming System uses older Instructions for Use (IFU) versions before Document #900-01-012 Rev. F or Cleaning and Sterilization Protocols before Document #900-06-011 Rev. E.
The recall is for updated dry time parameters in the Instructions for Use and Sterilization Protocols to ensure proper cleaning and sterilization of the Small Joint Reaming System.
Products with Instructions for Use versions before Document #900-01-012 Rev. F or Cleaning and Sterilization Protocols before Document #900-06-011 Rev. E are affected.
No action is needed if your product has the updated Instructions for Use (Document #900-01-012 Rev. F or later) and Cleaning and Sterilization Protocols (Document #900-06-011 Rev. E or later).
We’ve drafted a message you can send Trilliant Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1614-2020 — Trilliant Surgical Trilliant Surgical Hello, I own a Trilliant Surgical that is covered by recall Z-1614-2020 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.
