Alto Development Corp: Medical Device Recall in 2019 - (Recall #: Z-0245-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.
Product Description:

A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum.

Product Classification:

Class II

Date Initiated: September 10, 2019
Date Posted: November 6, 2019
Recall Number: Z-0245-2020
Event ID: 83942
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.

Status: Terminated
Product Quantity: 209 total
Code Information:

327144

Distribution Pattern:

Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI.

Voluntary or Mandated:

Voluntary: Firm initiated