3 — Class II medical device recall Z-0238-2019
Terminated recall by Synthes (USA) Products LLC, reported 2018-10-31, distributed in AR, AZ, FL, IL, NM, OH, TX. The product inside the package does not match the label. The product was labeled as long thread screws that ha
| Recall number | Z-0238-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2018-09-12 |
| Classified | 2018-10-24 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2020-04-10 |
| Distributed | AR, AZ, FL, IL, NM, OH, TX |
| Quantity | 20 |
| Reason classes | labeling |
| Lot numbers | L734474 |
| Model numbers | 04.226.118 |
Product
3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments.
Reason for recall
The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length.
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-0238-2019. 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.