Recall Z-1635-2020 ยท HTY Pin, Fixation, Smooth
Trilliant Surgical, LLC
8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202
| Date | Apr 1, 2020 (initiated Nov 4, 2019) |
| Status | Terminated |
| 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. |
| Root cause | Mixed-up of materials/components |
| Action | The recall strategy included sending complete recall communication and response forms as of 11/04/2019 via FedEx (Express Standard Overnight) to all consignees that showed possession / had been sold a device as of 10/30/2019. The recall communication included the following actions to be taken by the distributor/customer: 1. Check inventory stock for the identified device. 2. Open the shipper box* on the end opposite of the label and remove the internal packaging. *Note: Opening the shipper box does not disrupt the sterile barrier. The double sterile barrier is maintained within the inte |
| Quantity | 117 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121008 | TRILLIANT SURGICAL K-WIRES Trilliant Surgical, Ltd., Jun 4, 2012 |