Recall of outdated instructions for use and sterilization protocols for Trilliant Surgical Disco Subtalar Implant System Model 112-00-001 due to revised dry time parameters.
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Trilliant Surgical is recalling outdated instructions for use and sterilization protocols for their Disco Subtalar Implant System. This recall happened in 2018 because the old instructions didn't match the updated dry time requirements.
The outdated instructions could lead to improper sterilization or cleaning if dry time parameters are not followed correctly. This might cause infection or other complications during surgery.
Surgical teams using the Disco Subtalar Implant System Model 112-00-001 before 2018 may be affected. Surgeons and medical staff handling these implants are at risk if they follow outdated protocols.
Check for the Disco Subtalar Implant System Model 112-00-001 with IFUs before Document #900-01-005 Rev. N or Cleaning and Sterilization Protocols before Document #900-06-015 Rev. C.
Check if your instructions for use and sterilization protocols are from versions older than Document #900-01-005 Rev. N and Document #900-06-015 Rev. C.
The recall occurred in 2018 because the outdated instructions for use and sterilization protocols did not match the updated dry time requirements.
Check if your instructions for use and sterilization protocols are older than Document #900-01-005 Rev. N and Document #900-06-015 Rev. C. If so, review the updated protocols.
The official recall notice does not specify a deadline for action.
We’ve drafted a message you can send Trilliant Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1608-2020 — Trilliant Surgical Trilliant Surgical Hello, I own a Trilliant Surgical that is covered by recall Z-1608-2020 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.
