TriMed Hex Cortical Screw 4 — Class II medical device recall Z-1214-2019
Terminated recall by TriMed Inc., reported 2019-05-01, distributed in FL, MO. The bone screw is shorter than the intended design specification.
| Recall number | Z-1214-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TriMed Inc., Santa Clarita, CA, United States |
| Recall initiated | 2018-08-24 |
| Classified | 2019-04-23 |
| Reported by FDA | 2019-05-01 |
| Terminated | 2020-12-28 |
| Distributed | FL, MO |
| Quantity | 13 screws |
| UPC / GTIN / UDI-DI | 00842188107108 |
| Lot numbers | 170281 |
| Model numbers | HEX4.0-40 |
Product
TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The HEX4.0-40 screw is employed in combination with a TriMed Ankle Bone Plate such as a Sidewinder Plate, Ankle Hook Plate, Cluster, Semi-Tubular Plate, or the Locking Plate. Use of these implants is not a substitute for normal tissue healing. The TriMed Ankle Bone Plates and Screws are designed to provide additional constraint of movement of a fractured bone and are intended only as an aid to fix the fracture in place during the healing process.
Reason for recall
The bone screw is shorter than the intended design 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-1214-2019. 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.