Z-1042-2019 Class II Terminated
FDA device recall Z-1042-2019 was initiated by Smith & Nephew, Inc. on Dec 10, 2018 and is designated Class II. Reason for recall: Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch The recall status is terminated (terminated Nov 3, 2020). Affected quantity: 65 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 3, 2019
- Initiation Date
- Dec 10, 2018
- Termination Date
- Nov 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65 units
Product Description
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 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
Distribution Pattern
US Distribution to OR and TN; and Internationally to: Japan.
Code Information
Batch Numbers: 17JGA0020; 17JGA0020A; 17JGA0020B; 17JGA0026; 17JGA0026A; 17JGA0026B; 17JGA0032A; 17JGA0032B; 17JGA0042; 17JGA0042A; 17JGA0042R
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1042-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026