Z-1044-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2019
- Initiation Date
- December 10, 2018
- Termination Date
- November 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65 units
Product Description
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
Reason for Recall
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Distribution Pattern
US Distribution to OR and TN; and Internationally to: Japan.
Code Information
Batch Numbers: 17JGA0022; 17JGA0022A; 17JGA0022B; 17JGA0028; 17JGA0028A; 17JGA0028B; 17JGA0034A; 17JGA0034C; 17JGA0044; 17JGA0044B; 17JGA0044R; 18BGA0015A & 18BGA0015B