Data Foundry

Medical device recalls 2019

A&E Medical Thorecon Plating System Kits Model No — Class II medical device recall Z-0242-2020

Terminated recall by Alto Development Corp, reported 2019-11-06, distributed in AL, CA, FL, GA, IL, LA, MO, MS…. Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which o

Recall numberZ-0242-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAlto Development Corp, Wall Township, NJ, United States
Recall initiated2019-09-10
Classified2019-10-29
Reported by FDA2019-11-06
Terminated2020-05-12
DistributedAL, CA, FL, GA, IL, LA, MO, MS, NM, OK, SC, TX, UT, VT, WA, WI
Quantity209 total
Model numbers94-1200-08

Product

A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum.

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0242-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.