Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1635-2020 — 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202

U.S. FDA — Device Enforcement · United States · 2019-11-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1635-2020
Date of alert
2019-11-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Trilliant Surgical, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00812926022345
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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