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Recall Observatory FDA recall evidence

Device product

A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.

Z-0244-2020

September 10, 2019

Class II

Product summary

Firm
Alto Development Corp
Event
Event 83942
Status
Terminated
Classification
Class II
Quantity
209 total
Official record key
device-enforcement:Z-0244-2020

Official wording

Reason: 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.

Code information: 327705, 327706, 330587, 330588, 330753, 334396, 345417, 345418

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.