Recall Z-0243-2020— Alto Development Corp

Name: FDA recall Z-0243-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-10

Class II · Terminated

Class II FDA medical device recall by Alto Development Corp, initiated 2019-09-10, terminated 2020-05-12. It names one FDA 510(k) clearance: K181607. Product: A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.. Reason: Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable..

Recalling firm: Alto Development Corp
Classification: Class II
Status: Terminated
Initiated: 2019-09-10
Terminated: 2020-05-12
Firm location: Wall Township, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K181607 — Thorecon Rigid Fixation SystemA & E Medical Corporation·cleared 2018-10-12

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

A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.

Reason for recall

Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.

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