openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 5
A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum.
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.
These labels are deterministic app interpretations, not FDA categories.
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
327122, 327752, 328826, 328913, 334394
Distribution pattern
Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI.
device · product 2 of 5
A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.
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.
These labels are deterministic app interpretations, not FDA categories.
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
327703, 327704, 330464, 344282
Distribution pattern
Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI.
device · product 3 of 5
A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
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.
These labels are deterministic app interpretations, not FDA categories.
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
327144
Distribution pattern
Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI.
device · product 5 of 5
A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstruction of the sternum.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
