Device product
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 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-1043-2019
Product summary
- Event
- Event 81766
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65 units
- Official record key
device-enforcement:Z-1043-2019
Official wording
Reason: Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Code information: Batch Numbers: 17JGA0021; 17JGA0021A; 17JGA0027; 17JGA0027A; 17JGA0027B; 17JGA0033A; 17JGA0033B; 17JGA0043; 17JGA0043A; 17JGA0043B; 17JGA0043R; 17JGA0047 & 18BGA0014B
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