FDA Device 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
- FDA Device
- Class II
- terminated
- Published 2020-04-08
On 2020-04-08 the FDA classified a Class II recall of 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202 by Trilliant Surgical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1635-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-04 |
| Published | 2020-04-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Trilliant Surgical |
| Distribution | AR, AZ, CA, FL, GA, IA, IN, KS, KY, MN, MO, NC, ND, NJ, NY, OH, TN, TX, UT, WA, WI |
Product
8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202
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.
Identifiers
| code_info | Part Number: 220-08-003, Lot Number: TSL007202;Expiration Date: 12/25/2023. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1635-2020%22
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