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Lower risk Medical device recall · FDA · Published July 23, 2019

New Standard Device 'n'-Hole Post Recall: Thread Stripping During Application

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.

🇺🇸 FDA recall #Z-1824-2023Medical deviceNew Standard Device ›
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Contact the company

Recalling firmNew Standard Device Inc4848 Research Dr · San Antonio, TX 78240-5005
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/67367-new-standard-device-n-hole-post-recall-thread-stripping-during.

Source Summary by GovInfoNow · govinfonow.com/recall/67367-new-standard-device-n-hole-post-recall-thread-stripping-during · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1824-2023

Cite this page

“New Standard Device 'n'-Hole Post Recall: Thread Stripping During Application.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67367-new-standard-device-n-hole-post-recall-thread-stripping-during. Based on FDA recall #Z-1824-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1824-2023%22&limit=1).

New Standard Device Inc voluntarily recalled 'n'-Hole Posts, components of the Revolution External Fixation System, due to stripping threads during application, according to the FDA on July 23, 2019.

How to tell if you have it

  • Brand: New Standard Device
  • Product: 'n'-Hole Post (Revolution External Fixation System component)
  • Catalog Numbers: 100801, 100802, 100803, 100804, 100805
  • Lot Codes: A29318R, A29318S, A29318T, A29318U, A29318V
  • Units affected: 222

The hazard

The threads on the posts may strip out when tensioned during the application process.

Context

GovInfoNow's records show New Standard Device Inc has issued three other recalls since August 14, 2019. On December 28, 2020, the company recalled Metalogix Self-Drill Half-Pins due to tip breakage during surgery. Other recent recalls of similar products include Synthes 2.4V Tap Locking Screw Tap Recall (February 25, 2026) and SeaSpine Mariner Deformity Product Recall (August 19, 2026).

How to tell if you have this one

Check your Revolution External Fixation System for catalog numbers 100801 through 100805. The lot numbers associated with these catalogs are A29318R to A29318V.

  • Brand
    New Standard Device
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Your Device Model

    Identify if your Revolution External Fixation System uses catalog numbers 100801 through 100805.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 5 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: named in the noticeCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “U.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Connecticut, Ohio, Texas, Virginia.

Recall timeline

FDA published this recall 3.9 years after the firm started it.

1. Firm started the recall: Jul 23, 201912. FDA classified it Class II: Jun 9, 202323. Published in FDA’s Enforcement Report: Jun 21, 2023320192023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-1824-2023 (July 23, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1824-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA