Device product
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.
Z-1044-2019
Product summary
- Event
- Event 81766
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65 units
- Official record key
device-enforcement:Z-1044-2019
Official wording
Reason: Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Code information: Batch Numbers: 17JGA0022; 17JGA0022A; 17JGA0022B; 17JGA0028; 17JGA0028A; 17JGA0028B; 17JGA0034A; 17JGA0034C; 17JGA0044; 17JGA0044B; 17JGA0044R; 18BGA0015A & 18BGA0015B
Distribution pattern: US Distribution to OR and TN; and Internationally to: Japan.
Derived failure modes
-
Unknown
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch