New Standard Device Inc recalls 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803,…
- Recall date
- July 23, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1824-2023
- FDA classification
- Class II
- Brand / firm
- New Standard Device Inc
- Sold / distributed
- U.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.
Why it was recalled
The threads on posts stripping out when tensioned during application process.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
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