Mini Cannulated Titanium Headed and Headless Screw Set and 2 — Class II medical device recall Z-2679-2014
Terminated recall by Instratek, Incorporated, reported 2014-10-01, distributed nationwide. Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.
| Recall number | Z-2679-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instratek, Incorporated, Houston, TX, United States |
| Recall initiated | 2013-04-25 |
| Classified | 2014-09-22 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2016-01-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 96 |
| Lot numbers | 0001-0047, 918101, 918102, 918103 |
| Model numbers | 918101, 918102, 918103, IS1100, IS1103, IS1104, IS1105 |
Product
Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System
Reason for recall
Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.
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-2679-2014. 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.