Recall of outdated instructions for use and sterilization protocols for Trilliant Surgical Twist Sublatar Implant System Model 112-00-001 due to revised dry time parameters. Affected units sold in 2018.
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Trilliant Surgical is recalling outdated instructions for use and sterilization protocols for their Twist Sublatar Implant System. This recall happened in 2018 because the old instructions didn't match the latest cleaning and sterilization protocols.
The recall involves outdated instructions for use and sterilization protocols that don't match the current cleaning and sterilization procedures. This could lead to improper cleaning or sterilization if the old instructions are followed.
Surgical teams using the Twist Sublatar Implant System Model 112-00-001 before 2018 may be affected. Those who follow outdated instructions risk using incorrect cleaning protocols.
Check for the Twist Sublatar Implant System Model 112-00-001 with IFUs before Document #900-01-003 Rev. M or Cleaning and Sterilization Protocols before Document #900-06-015 Rev. C. Units sold in 2018 or earlier are affected.
Check if your device has instructions for use before Document #900-01-003 Rev. M or cleaning protocols before Document #900-06-015 Rev. C.
The recall is for outdated instructions for use and sterilization protocols that don't match the latest cleaning and sterilization procedures. This occurred in 2018.
Check if your device has instructions for use before Document #900-01-003 Rev. M or cleaning protocols before Document #900-06-015 Rev. C. No action is needed if you have the latest versions.
The recall indicates outdated instructions could lead to improper cleaning or sterilization, but no specific injury risk is stated in the record.
We’ve drafted a message you can send Trilliant Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1607-2020 — Trilliant Surgical Trilliant Surgical Hello, I own a Trilliant Surgical that is covered by recall Z-1607-2020 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.
