Device product
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , 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-1045-2019
Product summary
- Event
- Event 81766
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46 units
- Official record key
device-enforcement:Z-1045-2019
Official wording
Reason: Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Code information: Batch Numbers: 17JGA0023; 17JGA0023A; 17JGA0023C; 17JGA0029; 17JGA0029A; 17JGA0029B; 17JGA0035A; 17JGA0035C; 17JGA0045B; 17JGA0045C; 17JGA0045D & 17JGA0045R
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