Z-1635-2020 Class II Terminated
FDA device recall Z-1635-2020 was initiated by Trilliant Surgical, LLC on November 4, 2019 and is designated Class II. Reason for recall: 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 … The recall status is terminated (terminated April 28, 2021). Affected quantity: 117.
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2020
- Initiation Date
- November 4, 2019
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 117
Product Description
8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202
Reason for Recall
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.
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.
Code Information
Part Number: 220-08-003, Lot Number: TSL007202;Expiration Date: 12/25/2023.