Recall Z-1367-2021— Terumo Cardiovascular Systems Corporation
Class II · Terminated
Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2021-03-02, terminated 2021-11-05. FDA's recall record names no specific 510(k) clearance for this event. 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: There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture..
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-02
- Terminated
- 2021-11-05
- Firm location
- Elkton, MD, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.