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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Hazard
- Affected units
- 222
Distribution
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