Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1607-2020 — Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.

U.S. FDA — Device Enforcement · United States · 2018-07-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1607-2020
Date of alert
2018-07-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Trilliant Surgical, LLC
Product category
device
Product type
Devices
Reported risk: Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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