Device recall: 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI…
Class II FDA enforcement event 84987. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain the incorrect contents of the 8mm HTR Sterile Hammer Toe Reaming Kit. The kit should contain (2) reamers total, (1) Concave Reamer and (1) Convex Reamer; there is the potential that kits from the identified lot may have (2) of the same reamer type as opposed to one (1) of each type.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Trilliant Surgical, LLC started this device recall on 4 Nov 2019. The firm address in the FDA record is in Houston, TX. FDA put the recall in Class II. FDA event 84987 has 1 product record. The first FDA enforcement report date is 8 Apr 2020. The record gives the status Terminated, with the termination date 28 Apr 2021.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Distributors in 21 states: AR, AZ, CA, FL, GA, IA,IN, KS, KY, MN, MO, NC, ND, NJ, NY, OH, TN, TX, UT, WA, and WI.
Recalling firm
Trilliant Surgical, LLC, Houston, TX.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1635-2020 | 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202 | 117 | Class II | Terminated | 8 Apr 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 10 Oct 2019 | 3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage | Device | Class II | 1 |
| 14 Mar 2019 | Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal. | Device | Class II | 1 |
| 19 Jul 2018 | Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Tiger Cannulated Screw | Device | Class II | 10 |
Official channels
- FDA enforcement report Z-1635-2020The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 84987. https://recallregister.com/fda/ii/84987/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Distributors in 21 states: AR, AZ, CA, FL, GA, IA,IN, KS, KY, MN, MO, NC, ND, NJ, NY, OH, TN, TX, UT, WA, and WI.
- What quantity of product is in FDA event 84987?
- The FDA record gives this quantity:
117
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.