Recall Z-0599-2020— Toby Orthopaedics, Inc.

Name: FDA recall Z-0599-2020
Creator: U.S. Food and Drug Administration
Published: 2013-06-05

Class II · Terminated

Class II FDA medical device recall by Toby Orthopaedics, Inc., initiated 2013-06-05, terminated 2020-09-16. It names one FDA 510(k) clearance: K081608. Product: PANTERA Proximal Humerus Fracture Plate System. Reason: Potential suture clip breaking during a humerus fixation surgery..

Recalling firm: Toby Orthopaedics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-06-05
Terminated: 2020-09-16
Firm location: West Miami, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K081608 — PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)Toby Orthopaedics, LLC·cleared 2008-12-19

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

PANTERA Proximal Humerus Fracture Plate System

Reason for recall

Potential suture clip breaking during a humerus fixation surgery.

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