FDA recall Z-0243-2020

Product

A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. 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

Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI.

Key facts

Status

Terminated

Initiation date

2019-09-10

Report date

2019-11-06

Termination date

2020-05-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wall Township, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0243-2020