Z-1824-2023Class II

'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801...

Name: Z-1824-2023 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801...
Creator: New Standard Device Inc
Published: 2019-07-23
License: https://open.fda.gov/license/

Fusion Orthopedics USA, LLC / initiated 2019-07-23 / Open, Classified

FDA source

New Standard Device Inc began a recall of 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805 on 2019-07-23. FDA classified it as Class II and gives the reason as "The threads on posts stripping out when tensioned during application process". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1824-2023
Classification: Class II
Status: Open, Classified
Initiated: 2019-07-23
Posted: 2023-06-09
Recalling firm: Fusion Orthopedics USA, LLC
Product: 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: The threads on posts stripping out when tensioned during application process.
FDA root cause: Under Investigation by firm
Action: On 07/23/2019, the firm emailed a "FIELD SAFETY NOTICE" Letter to customers informing them that threads on posts were stripping out when tensioned during application process. Customers were instructed to: 1. Remove remaining POSTS from their inventory and return to Metalogix Inc. at 4848 Research Drive, San Antonio, TX 78240 Please label return package "ATTENTION: QA Dept" Metalogix Fed-Ex Account# 845 986 983 Metalogix will expedite new product back to customers For further information or questions, contact: Rachel Grimes, Quality Assurance Manager at 833-659-2019, EXT 6 [email protected]
Quantity in commerce: 222 units
Distribution: U.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.
Product codes and lots: Catalog Numbers / Lot Numbers: 100801 / A29318R 100802 / A29318S 100803 / A29318T 100804 / A29318U 100805 / A29318V UDI Codes: Not provided/None

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1824-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1824-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-09

Product code KTT

K181630Class IIRevolution External Plating SystemNew Standard Device Dba Metalogix / cleared 2019-05-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)