Device product
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 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-1042-2019
Product summary
- Event
- Event 81766
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65 units
- Official record key
device-enforcement:Z-1042-2019
Official wording
Reason: Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Code information: Batch Numbers: 17JGA0020; 17JGA0020A; 17JGA0020B; 17JGA0026; 17JGA0026A; 17JGA0026B; 17JGA0032A; 17JGA0032B; 17JGA0042; 17JGA0042A; 17JGA0042R
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