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Recall Observatory FDA recall evidence

Device product

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

Z-1635-2020

November 04, 2019

Class II

Product summary

Firm
Trilliant Surgical, LLC
Event
Event 84987
Status
Terminated
Classification
Class II
Quantity
117
Official record key
device-enforcement:Z-1635-2020

Official wording

Reason: 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.

Code information: Part Number: 220-08-003, Lot Number: TSL007202;Expiration Date: 12/25/2023.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.