RecallRadar

FDA Device recall Z-1605-2020

Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-…

On 2020-04-08 the FDA classified a Class II recall of Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-… by Trilliant Surgical, citing instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1605-2020
ClassificationClass II
Statusterminated
Initiated2018-07-19
Published2020-04-08
Last updated2026-09-13 11:55 UTC
CompanyTrilliant Surgical
DistributionAZ, CA, CT, FL, GA, IA, IL, IN, LA, MD, MI, MN, MO, MT, ND, NE, NH, NJ, OH, OK, PA, PR, SD, TN, TX, VA, WA, WI, WY

Product

Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-00-001; and (2) Combination Tiger/Tiger Headless Cannulated Screw System, Model 210-00-101. The firm name on the label is Trilliant Surgical, Houston, TX.

Reason

Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

Identifiers

code_infoIFUs previous to Document #900-01-002 Rev. P and Cleaning and Sterilization Protocols previous to Document #900-06-007 Rev. F.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1605-2020%22

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