Z-1367-2021 Class II Terminated
FDA device recall Z-1367-2021 was initiated by Terumo Cardiovascular Systems Corporation on March 2, 2021 and is designated Class II. Reason for recall: There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture. The recall status is terminated (terminated November 5, 2021). Affected quantity: 12.
Recall Details
- Product Type
- Devices
- Report Date
- April 14, 2021
- Initiation Date
- March 2, 2021
- Termination Date
- November 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12
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.
Distribution Pattern
US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.
Code Information
GTIN Code: (01)00699753450950 Catalog Number: T401163 Serial Numbers: T00393, T00394, T00395, T00399, T00403, T00405, T00406, T00407, T00408, T00410, T00411, T00412.