'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
FDA Recall Z-1824-2023 · Posted 2023-06-09
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Recalling FirmNew Standard Device Inc
Recall StatusOpen, Classified
Product CodeKTT
Date Initiated2019-07-23
Product Quantity222 units
Reason for Recall
The threads on posts stripping out when tensioned during application process.
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]
Root Cause
Under Investigation by firm
Distribution Pattern
U.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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