'n'-Hole Post which is a component of the Revolution External… — Class II medical device recall Z-1824-2023
Ongoing recall by New Standard Device Inc, reported 2023-06-21, distributed nationwide. The threads on posts stripping out when tensioned during application process.
| Recall number | Z-1824-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | New Standard Device Inc, San Antonio, TX, United States |
| Recall initiated | 2019-07-23 |
| Classified | 2023-06-09 |
| Reported by FDA | 2023-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 222 units |
| Lot numbers | 100801, 100802, 100803, 100804, 100805, A29318R, A29318S, A29318T, A29318U, A29318V |
| Model numbers | 100801, 100802, 100803, 100804, 100805 |
Product
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
Reason for recall
The threads on posts stripping out when tensioned during application process.
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-1824-2023. 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.