Reported Apr 8, 2020 · Terminated

8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI:…

Trilliant Surgical, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Trilliant Surgical, LLC · 727 N Shepherd Dr Ste 100 · Houston, TX · 77007-1320

Is this the product you have?

  • 8mm HTR Sterile Hammer Toe Reaming Kit
  • MaterialStainless Steel
  • SterileR, PX only
  • UDI(01)00812926022345(17)231225 (10)TSL007202
Lot codes and dates
  • Part Number220-08-003
  • Lot NumberTSL007202
  • Expiration Date12/25/2023
Amount recalled
117

This recall covers 11 products

The agency filed one notice per product. You are reading one of them; the other 10 are below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 28, 2021 · Data as of Sep 19, 5:30 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.