'n'-Hole Post which is a component of the Revolution recall
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
Why was 'n'-Hole Post which is a component of the Revolution recalled?
The threads on posts stripping out when tensioned during application process.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Numbers / Lot Numbers: 100801 / A29318R 100802 / A29318S 100803 / A29318T 100804 / A29318U 100805 / A29318V UDI Codes: Not provided/None
- Product
- 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
- Recalling firm
- New Standard Device Inc
- Quantity
- 222 units
- Distribution
- U.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.
- Recall date
- June 21, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)