New Standard Device 'n'-Hole Post which is a component of the Revolution External Fixation recall — FDA Z-1824-2023
The threads on posts stripping out when tensioned during application process.
Overview of recall records associated with New Standard Device Inc., including dates, categories and classifications where available.
Classification mix: Class II: 3.
The threads on posts stripping out when tensioned during application process.
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are meant to provide a stronger wire and…
This page summarizes recall records in which the official source identifies New Standard Device Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.