Z-0246-2020 Class II Terminated
FDA device recall Z-0246-2020 was initiated by Alto Development Corp on September 10, 2019 and is designated Class II. 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. The recall status is terminated (terminated May 12, 2020). Affected quantity: 209 total.
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2019
- Initiation Date
- September 10, 2019
- Termination Date
- May 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 209 total
Product Description
A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. 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.
Distribution Pattern
Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI.
Code Information
327150, 327151, 327152, 327707, 340284, 343232, 343236