2 — Class II medical device recall Z-2421-2015
Terminated recall by Trilliant Surgical Ltd., reported 2015-08-26, distributed nationwide. The cutting efficiency of the Countersinks was out of specification.
| Recall number | Z-2421-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trilliant Surgical Ltd., Houston, TX, United States |
| Recall initiated | 2015-07-20 |
| Classified | 2015-08-19 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2017-01-26 |
| Distributed | Nationwide (US) |
| Quantity | 102 units |
| Reason classes | specification failure |
| Lot numbers | 1362-01, 1364-01 |
| Model numbers | 210-24-002, 210-40-002, 3.0/4.0 |
Product
2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis, and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.
Reason for recall
The cutting efficiency of the Countersinks was out of specification.
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-2421-2015. 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.