JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 — Class II medical device recall Z-1045-2019
Terminated recall by Smith & Nephew, Inc., reported 2019-04-03, distributed in OR, TN. Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
| Recall number | Z-1045-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2018-12-10 |
| Classified | 2019-03-22 |
| Reported by FDA | 2019-04-03 |
| Terminated | 2020-11-03 |
| Distributed | OR, TN |
| Countries outside the US | JP |
| Quantity | 46 units |
| Reason classes | device malfunction |
| Lot numbers | 17JGA0023, 17JGA0023A, 17JGA0023C, 17JGA0029, 17JGA0029A, 17JGA0029B, 17JGA0035A, 17JGA0035C, 17JGA0045B, 17JGA0045C, 17JGA0045D, 17JGA0045R |
| Model numbers | 74013988 |
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 for recall
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1045-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.