Z-1635-2020Class II

8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI...

Name: Z-1635-2020 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI...
Creator: Trilliant Surgical, LLC
Published: 2019-11-04
License: https://open.fda.gov/license/

Trilliant Surgical LLC / initiated 2019-11-04 / Terminated / root cause: sterility

FDA source

Trilliant Surgical, LLC began a recall of 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202 on 2019-11-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1635-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-04
Posted: 2020-04-01
Terminated: 2021-04-28
Recalling firm: Trilliant Surgical LLC
Product: 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202
Product code: HTY Pin, Fixation, Smooth
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.
Root cause tag: sterility
FDA 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 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.
Quantity in commerce: 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.
Product codes and lots: Part Number: 220-08-003, Lot Number: TSL007202;Expiration Date: 12/25/2023.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1635-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1635-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-04-01

Product code HTY

K121008Class IITrilliant Surgical K-WiresTrilliant Surgical, Ltd. / cleared 2012-06-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)