A&E Medical Thorecon Plating System Kits recalled over mold contamination

Recall date

September 10, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

Z-0243-2020

FDA classification

Class II

Brand / firm

Alto Development Corp

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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