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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84977

10 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 19, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Trilliant Surgical, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

10 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 10

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.

Z-1605-2020
Recall number
Z-1605-2020
Initiated
July 19, 2018
Classification
Class II
Status
Terminated
Recalling firm
Trilliant Surgical, LLC
Quantity
170 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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.

device · product 2 of 10

Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Headless Cannulated Screw System, Model 212-00-001; and (2) Combination Tiger Cannulated/Tiger Headless Cannulated Screw System, Model 210-00-101. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

Z-1606-2020
Recall number
Z-1606-2020
Initiated
July 19, 2018
Classification
Class II
Status
Terminated
Recalling firm
Trilliant Surgical, LLC
Quantity
28 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

IFUs previous to Document #900-01-004 Rev. P and Cleaning and Sterilization Protocols previous to Document #900-06-007 Rev. F.

Distribution pattern

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.

device · product 3 of 10

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.

Z-1607-2020
Recall number
Z-1607-2020
Initiated
July 19, 2018
Classification
Class II
Status
Terminated
Recalling firm
Trilliant Surgical, LLC
Quantity
4 systems total for both Twist Sublatar and Disco Sublatar

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

IFUs previous to Document #900-01-003 Rev. M and Cleaning and Sterilization Protocols previous to Document #900-06-015 Rev. C.

Distribution pattern

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.

device · product 4 of 10

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.

Z-1608-2020
Recall number
Z-1608-2020
Initiated
July 19, 2018
Classification
Class II
Status
Terminated
Recalling firm
Trilliant Surgical, LLC
Quantity
4 systems total for both Disco Sublatar and Twist Sublatar

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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.

device · product 5 of 10

Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Plating System, Model 310-01-100. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

Z-1609-2020
Recall number
Z-1609-2020
Initiated
July 19, 2018
Classification
Class II
Status
Terminated
Recalling firm
Trilliant Surgical, LLC
Quantity
8 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

IFUs previous to Document #900-01-006 Rev. N and Cleaning and Sterilization Protocols previous to Document #900-06-014 Rev. C.

Distribution pattern

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.

device · product 6 of 10

Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Two-Step Hammertoe Implant System, Model 214-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

Z-1610-2020
Recall number
Z-1610-2020
Initiated
July 19, 2018
Classification
Class II
Status
Terminated
Recalling firm
Trilliant Surgical, LLC
Quantity
17 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

IFUs previous to Document #900-01-008 Rev. N and Cleaning and Sterilization Protocols previous to Document #900-06-016 Rev. C.

Distribution pattern

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.

device · product 7 of 10

Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd 3S Hemi Toe Implant System, Model 111-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

Z-1611-2020
Recall number
Z-1611-2020
Initiated
July 19, 2018
Classification
Class II
Status
Terminated
Recalling firm
Trilliant Surgical, LLC
Quantity
9 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

IFUs previous to Document #900-01-009 Rev. I and Cleaning and Sterilization Protocols previous to Document #900-06-008 Rev. H.

Distribution pattern

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.

device · product 8 of 10

Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System, Model 215-00-001; and (2) Trilliant Surgical Ltd Large Cannulated Headless Screw System, Model 215-00-001. The firm name on the label is Trilliant Surgical Ltd., Houston, TX.

Z-1612-2020
Recall number
Z-1612-2020
Initiated
July 19, 2018
Classification
Class II
Status
Terminated
Recalling firm
Trilliant Surgical, LLC
Quantity
4 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

(1) Trilliant Surgical Tiger Large Cannulated Screw System - IFUs previous to Document #900-01-010 Rev. I and Cleaning and Sterilization Protocols previous to Document #900-06-009 Rev. F; and (2) Trilliant Surgical Large Cannulated Headless Screw System - IFUs previous to Document 900-01-014 Rev G and Cleaning and Sterilization Protocols previous to Document #900-06-012 Rev. D.

Distribution pattern

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.

device · product 9 of 10

Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Ankle Plating System, Model 320-01-100. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

Z-1613-2020
Recall number
Z-1613-2020
Initiated
July 19, 2018
Classification
Class II
Status
Terminated
Recalling firm
Trilliant Surgical, LLC
Quantity
3 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

IFUs previous to Document #900-01-011 Rev. K and Cleaning and Sterilization Protocols previous to Document #900-06-010 Rev. G.

Distribution pattern

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.

device · product 10 of 10

Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Small Joint Reaming System, Model 311-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

Z-1614-2020
Recall number
Z-1614-2020
Initiated
July 19, 2018
Classification
Class II
Status
Terminated
Recalling firm
Trilliant Surgical, LLC
Quantity
2 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

IFUs previous to Document #900-01-012 Rev. F and Cleaning and Sterilization Protocols previous to Document #900-06-011 Rev. E.

Distribution pattern

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.