FDA Medical Device Recalls (openFDA)
New Standard Device Inc: 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
- Recall number
- Z-1824-2023
- Recalling firm
- New Standard Device Inc
- Product
- 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
- Status
- Open, Classified
- Initiated
- 2019-07-23
- Posted
- 2023-06-09
- Terminated
- not on file
- Reason
- The threads on posts stripping out when tensioned during application process.
- 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 rachel@metalogix.life
- Quantity
- 222 units
- Distribution
- U.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.
- Lot, serial or model codes
- Catalog Numbers / Lot Numbers: 100801 / A29318R 100802 / A29318S 100803 / A29318T 100804 / A29318U 100805 / A29318V UDI Codes: Not provided/None
- 510(k) numbers
- ["K181630"]
- PMA numbers
- not on file
- Product code
- KTT
- Firm FEI
- 3013365802
- Firm city
- San Antonio
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28