2 — Class II medical device recall Z-2738-2015
Terminated recall by Trilliant Surgical Ltd., reported 2015-09-16, distributed in AR, AZ, CA, FL, GA, IA, IL, IN…. Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specification and have
| Recall number | Z-2738-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trilliant Surgical Ltd., Houston, TX, United States |
| Recall initiated | 2015-07-31 |
| Classified | 2015-09-04 |
| Reported by FDA | 2015-09-16 |
| Terminated | 2017-01-26 |
| Distributed | AR, AZ, CA, FL, GA, IA, IL, IN, MN, MO, NJ, NY, OH, OK, SC, SD, TX, VA, WI |
| Quantity | 108 units |
| Reason classes | specification failure |
| Lot numbers | TSL002605 |
| Model numbers | 310-30-003 |
Product
2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones.
Reason for recall
Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specification and have the potential for shallow engagement between the driver and the screw, resulting in an increased likelihood of stripping screw heads intraoperatively. Specifically, the minor diameter of the drive feature is above the specification, potentially reducing the engagement between the driver and the screw head.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2738-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.