The Recall Desk
HighFDA (Devices)·Z-1824-2023·Announced 2023-06-21

External Fixation System Post Component Recall Due to Thread Stripping

New Standard Device Inc is recalling 222 units of 'n'-Hole Posts used in the Revolution External Fixation System because the threads strip out during tensioning, potentially compromising fracture fixation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall of a medical device component with a structural defect (threads stripping during application). While no injuries or hospitalizations are explicitly reported in the source, the defect poses a risk to patient safety by potentially compromising proper fixation in an orthopedic external fixation system.

Plain-English summary

New Standard Device Inc is recalling 222 units of the 'n'-Hole Post, a component of the Revolution External Fixation System used in orthopedic surgical procedures for fracture fixation and stabilization.

The threads on the posts are stripping out when tensioned during the application process. This defect could compromise the proper fixation and stability of the external fixation system.

The affected units were distributed in Arizona, Connecticut, Ohio, Texas, and Virginia. The recalled lot numbers are A29318R, A29318S, A29318T, A29318U, and A29318V, corresponding to catalog numbers 100801 through 100805.

Clinicians using affected units should discontinue use immediately and contact New Standard Device Inc for instructions regarding replacement or return of the product.

The recalled product

Product
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
Manufacturer
New Standard Device Inc
Category
Medical Device — Orthopedic / External Fixation Component
Hazard
Affected units
222

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Related recalls

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