Tibial Nail — Class II medical device recall Z-2393-2018
Terminated recall by Stryker GmbH, reported 2018-07-18, distributed in FL, KY, NC, TN, UT, WA. The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-
| Recall number | Z-2393-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker GmbH, Selzach, Switzerland |
| Recall initiated | 2018-04-27 |
| Classified | 2018-07-10 |
| Reported by FDA | 2018-07-18 |
| Terminated | 2020-05-21 |
| Distributed | FL, KY, NC, TN, UT, WA |
| Quantity | 12 |
| Reason classes | potency, device malfunction |
| UPC / GTIN / UDI-DI | 04546540197771 |
| Lot numbers | K074846 |
Product
Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S
Reason for recall
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
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-2393-2018. 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.