Recall Z-0242-2020 ยท JDQ Cerclage, Fixation
Alto Development Corp
A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum.
| Date | Sep 10, 2019 |
| 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. |
| Root cause | Process control |
| Action | On September 10, 2019, the firm distributed a letter to customers titled Product Recall: Action Required. The letter informed customers of the potential tensioner failure. Customers were given two options: 1. A&E will provide a supply of individually packaged, sterile tensioners to be kept on hand should a kit tensioner be found inoperable. Surgeons and Operating Room staff need to be alerted to this situation and the stock of additional tensioners readily available to them during surgery. 2. For those customers who prefer to return their affected lots of Thorecon, A&E will provide a Returned |
| Quantity | 209 total |
| Distribution | Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181607 | Thorecon Rigid Fixation System A & E Medical Corporation, Oct 12, 2018 |