FDA Device recall Z-1045-2019
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instru…
- FDA Device
- Class II
- terminated
- Published 2019-04-03
On 2019-04-03 the FDA classified a Class II recall of JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instru… by Smith And Nephew, citing higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1045-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-10 |
| Published | 2019-04-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Smith And Nephew |
| Distribution | OR, TN |
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.
Reason
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Identifiers
| code_info | Batch Numbers: 17JGA0023; 17JGA0023A; 17JGA0023C; 17JGA0029; 17JGA0029A; 17JGA0029B; 17JGA0035A; 17JGA0035C; 17JGA0045B; 17JGA0045C; 17JGA0045D & 17JGA0045R |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1045-2019%22
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