Recall Z-2132-2020 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Smith & Nephew, Inc.
JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional moveable spikes (spike rail) aids in provisional fixation of the trial. SIZE 1, CATALOG NUMBER: REF 74035821 SIZE 2, CATALOG NUM
| Date | Jan 28, 2020 |
| Status | Terminated |
| Reason | The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble. |
| Root cause | Process design |
| Action | The firm initiated the recall by email on 01/28/2020. The initial consignee notified the district sales representatives on 01/28/2020 by email. The district sales representatives checked their inventory and the inventory of the hospital they service. |
| Quantity | 200 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190085 | Journey II Unicompartmental Knee System Smith & Nephew, Inc., Feb 11, 2019 |