FDA Device recall Z-1043-2019
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 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 3-4 , REF 74013987 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-1043-2019 |
| 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 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.
Reason
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Identifiers
| code_info | Batch Numbers: 17JGA0021; 17JGA0021A; 17JGA0027; 17JGA0027A; 17JGA0027B; 17JGA0033A; 17JGA0033B; 17JGA0043; 17JGA0043A…Batch Numbers: 17JGA0021; 17JGA0021A; 17JGA0027; 17JGA0027A; 17JGA0027B; 17JGA0033A; 17JGA0033B; 17JGA0043; 17JGA0043A; 17JGA0043B; 17JGA0043R; 17JGA0047 & 18BGA0014B |
|---|
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-1043-2019%22
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