FDA recall Z-1367-2021

Product

Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.

Reason for recall

There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.

Distribution

US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.

Key facts

Status

Terminated

Initiation date

2021-03-02

Report date

2021-04-14

Termination date

2021-11-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Elkton, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1367-2021