Trilliant Surgical recalls outdated instructions for use and sterilization protocols for Two-Step Hammertoe implants. Updated protocols may affect safe cleaning and sterilization.
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Trilliant Surgical is recalling outdated instructions for use and sterilization protocols for their Two-Step Hammertoe implant system. This recall affects products sold in 2018 and may lead to improper cleaning or sterilization if users follow old protocols.
The recall involves outdated instructions for use and sterilization protocols that may not properly guide cleaning and sterilization steps. If users follow old protocols, there could be a risk of improper sterilization, but this is unlikely to cause serious injury in normal surgical use.
Surgical teams using Trilliant Surgical's Two-Step Hammertoe implant system, particularly those with older instructions or sterilization protocols. Patients undergoing the procedure are at low risk if the implant is used correctly.
Check for the product name 'Two-Step Hammertoe Implant System' with model number 214-00-001. The recall applies to versions of the instructions and protocols before Document #900-01-008 Rev. N and Document #900-06-016 Rev. C, sold in 2018.
Check if your instructions and sterilization protocols are updated to Document #900-01-008 Rev. N or later for instructions, and Document #900-06-016 Rev. C or later for sterilization protocols.
No, the recall is for outdated instructions and protocols, not the implant itself. The implant can still be used safely if current protocols are followed.
Check for model number 214-00-001 and instructions/protocols older than Document #900-01-008 Rev. N or Document #900-06-016 Rev. C, sold in 2018.
The recall is for outdated instructions, not the implant. There is no risk of injury if current protocols are followed; the hazard is low risk.
We’ve drafted a message you can send Trilliant Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1610-2020 — Trilliant Surgical Trilliant Surgical Hello, I own a Trilliant Surgical that is covered by recall Z-1610-2020 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.
