Recall Z-1649-2022— New Standard Device Inc

Name: FDA recall Z-1649-2022
Creator: U.S. Food and Drug Administration
Published: 2020-12-28

Class II · Ongoing

Class II FDA medical device recall by New Standard Device Inc, initiated 2020-12-28. It names one FDA 510(k) clearance: K181630. Product: Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080. Reason: Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery..

Recalling firm: New Standard Device Inc
Classification: Class II
Status: Ongoing
Initiated: 2020-12-28
Firm location: San Antonio, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K181630 — Revolution External Plating SystemNew Standard Device Dba Metalogix·cleared 2019-05-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080

Reason for recall

Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.

Data sourced from openFDA. This site is unofficial and independent of the FDA.