New Standard Device recalls 'n'-Hole Post components (catalogs 100801-100805) due to thread stripping during application. Affected users should check their device model and contact for remedy.
The threads on posts stripping out when tensioned during application process.
New Standard Device is recalling 'n'-Hole Post components used in their Revolution External Fixation System. The posts can strip threads when tightened during application, potentially causing failure. This affects users who have the specific catalog numbers listed.
The threads on the posts can strip out when tensioned during application. This may cause the post to fail under stress, potentially leading to improper fixation of the device.
Users of the Revolution External Fixation System with the specified catalog numbers (100801-100805) are affected. Patients or medical professionals using these components during treatment are most at risk.
Check your Revolution External Fixation System for catalog numbers 100801 through 100805. The lot numbers associated with these catalogs are A29318R to A29318V.
Identify if your Revolution External Fixation System uses catalog numbers 100801 through 100805.
The threads can strip out when tensioned during application, potentially causing the post to fail.
Check your Revolution External Fixation System for catalog numbers 100801 through 100805 with corresponding lot numbers A29318R to A29318V.
The recall does not specify a remedy, so contact New Standard Device for further instructions.
We’ve drafted a message you can send New Standard Device to request your refund or repair — edit it as you like.
Subject: Recall Z-1824-2023 — New Standard Device New Standard Device Hello, I own a New Standard Device that is covered by recall Z-1824-2023 from New Standard Device. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
