FDA-Device2019-11-06Class II
A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum.
Alto Development Corp
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.
Sold states
Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI.
Affected count
209 total
Manufactured in
5206 Asbury Rd, Wall Township, NJ, United States
Products
A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0245-2020Don't want to check this manually?
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