Device 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.
Z-1367-2021
Product summary
- Event
- Event 87504
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12
- Official record key
device-enforcement:Z-1367-2021
Official wording
Reason: There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
Code information: GTIN Code: (01)00699753450950 Catalog Number: T401163 Serial Numbers: T00393, T00394, T00395, T00399, T00403, T00405, T00406, T00407, T00408, T00410, T00411, T00412.
Distribution pattern: US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.
Derived failure modes
-
Unknown
There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.