Class II — Alto Development Corp
| Recalling firm | ALTO DEVELOPMENT CORP. |
|---|---|
| Registered facility | ALTO DEVELOPMENT CORP. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstruction of the sternum. |
| Quantity | 209 total |
| Distribution | Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI. |
| Initiated | 2019-09-10 |
| Classified | 2019-10-29 |
| Terminated | 2020-05-12 |
| Recall number | Z-0246-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Alto Development Corp (Z-0246-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83942/
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