Food, drugs, devices › Alto Development Corp
Device recall: A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum.
FDA enforcement event 83942 is a device recall by Alto Development Corp of Wall Township, NJ, initiated 10 Sep 2019 and classified Class II, with 5 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 12 May 2020. Initiation: voluntary: firm initiated. Alto Development Corp has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Alto Development Corp, Wall Township, NJ.
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."
Distribution
"Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0242-2020 | A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum. | 209 total | Class II | Terminated | 6 Nov 2019 |
| Z-0243-2020 | A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum. | 209 total | Class II | Terminated | 6 Nov 2019 |
| Z-0244-2020 | A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum. | 209 total | Class II | Terminated | 6 Nov 2019 |
| Z-0245-2020 | A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum. | 209 total | Class II | Terminated | 6 Nov 2019 |
| Z-0246-2020 | A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstruction of the sternum. | 209 total | Class II | Terminated | 6 Nov 2019 |
Context
Other enforcement events for Alto Development Corp
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 21 Jun 2019 | A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing | Device | Class II | 1 |
| 23 Oct 2017 | Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in | Device | Class II | 1 |
All 3 events for Alto Development Corp
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 12 May 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.