Trilliant Surgical, LLC 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202
Brand
Trilliant Surgical, LLC
Lot Codes / Batch Numbers
Part Number: 220-08-003, Lot Number: TSL007202, Expiration Date: 12/25/2023.
Products Sold
Part Number: 220-08-003, Lot Number: TSL007202;Expiration Date: 12/25/2023.
Trilliant Surgical, LLC is recalling 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00 due to 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 To. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 internal packaging. 3. Through the transparent internal packaging, verify that the kit contains the appropriate quantity and type of each reamer; (1) Concave Reamer and (1) Convex Reamer. If product in possession IS identified as affected by containing (2) of the same reamer type, quarantine and/or discontinue use of the device and return the affected device(s) to the firm in accordance with the included Return Response (Acknowledgment and Receipt Form). If product in possession IS NOT affected (i.e. there is 1 Concave Reamer and 1 Convex Reamer within the packaging, complete and return the included Return Response (Acknowledgment and Receipt Form). THE INCLUDED RETURN RESPONSE IS REQUIRED EVEN IF AFFECTED PRODUCT IS NOT IDENTIFIED. For questions regarding the communication, the phone number is 800.495.2919.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, AR, CA, FL, GA, IN, IA, KS, KY, MN, MO, NJ, NY, NC, ND, OH, TN, TX, UT, WA, WI
Page updated: Jan 10, 2026