FDASeptember 10, 2019device

A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstruction of the sternum.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

alto developmentalto

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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