CLASS II Device recall · Reported 8 Apr 2020 · FDA Enforcement Report

Instructions for Use and Surgical Cleaning recalled

Trilliant Surgical is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant, distributed in 29 states. The recall was initiated on 19 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesIFUs previous to Document #900-01-005 Rev. N and Cleaning and Sterilization Protocols previous to Document #900-06-015 Rev. C.

Quantity recalled4 systems total for both Disco Sublatar and Twist Sublatar

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1608-2020
FDA event ID: 84977
Recalling firm: Trilliant Surgical, Houston, TX
Classification: Class II
Status: Terminated
Recall initiated: 19 Jul 2018
FDA classified: 30 Mar 2020
Reported: 8 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

19 Jul 2018	Recall initiated by company
30 Mar 2020	Classified by FDA	+620 days
8 Apr 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Disco Subtalar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.

Where it was distributed

Distribution to US states: AZ, CA, CT, FL, GA, IA, IL, IN, LA, MD, MI, MN, MO, MT, ND, NE, NH, NJ, OH, OK, PA, SD, TN, TX, VA, WA, WI, WY, and PR. There was government distribution and no military distribution. Foreign distribution to Australia, India, Italy, Panama, and Turkey.

Arizona California Connecticut Florida Georgia Iowa Illinois Indiana Louisiana Maryland Michigan Minnesota Missouri Montana North Dakota Nebraska New Hampshire New Jersey Ohio Oklahoma

Questions about this recall

Is Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant recalled?

Yes. Trilliant Surgical recalled Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant on 19 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-1608-2020.

Why was it recalled?

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

Which lots are affected?

IFUs previous to Document #900-01-005 Rev. N and Cleaning and Sterilization Protocols previous to Document #900-06-015 Rev. C.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Trilliant Surgical

All 23

Reported	Class	Recall	Company	Reason	Where
13 May 2020Device	CLASS II	Aresenal Screw Drill Bit recalled by Trilliant Surgical	Trilliant Surgical	Labeling Errors	Nationwide
8 Apr 2020Device	CLASS II	Instructions for Use and Surgical Cleaning recalled	Trilliant Surgical	Sterility	29 states
8 Apr 2020Device	CLASS II	Instructions for Use and Surgical Cleaning recalled	Trilliant Surgical	Sterility	29 states
8 Apr 2020Device	CLASS II	Instructions for Use and Surgical Cleaning recalled	Trilliant Surgical	Sterility	29 states
8 Apr 2020Device	CLASS II	Instructions for Use and Surgical Cleaning recalled	Trilliant Surgical	Sterility	29 states

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