FDA Device recall Z-1824-2023
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
- FDA Device
- Class II
- ongoing
- Published 2023-06-21
On 2023-06-21 the FDA classified a Class II recall of 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805 by New Standard Device, citing the threads on posts stripping out when tensioned during application process.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1824-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-07-23 |
| Published | 2023-06-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | New Standard Device |
| Distribution | US |
Product
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
Reason
The threads on posts stripping out when tensioned during application process.
Identifiers
| code_info | Catalog Numbers / Lot Numbers: 100801 / A29318R 100802 / A29318S 100803 / A29318T 100804 / A29318U 100805 / A29318V UDI Codes: Not provided/None |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1824-2023%22
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