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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
Recalled November 6, 2019 · FDA recall Z-0243-2020 · Alto Development
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. · FDA Class II
Units
209 total
Sold at
Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI.
Description
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.
Product
A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.
Manufacturer(s)
Alto Development Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →