FDAFDA · Food and drugs·Recall number Z-1635-2020
8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202
Published April 8, 2020 · Recall initiated: November 4, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Trilliant Surgical, LLC
- Distributor
- 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.
- Lot
- Part Number: 220-08-003, Lot Number: TSL007202;Expiration Date: 12/25/2023.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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