FDA Device recall Z-2133-2020
JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surg…
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surg… by Smith And Nephew, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2133-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-28 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Smith And Nephew |
| Distribution | US |
Product
JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT 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 74035831 SIZE 2, CATALOG NUMBER: REF 74035832 SIZE 3, CATALOG NUMBER: REF 74035833 SIZE 4, CATALOG NUMBER: REF 74035834 SIZE 5, CATALOG NUMBER: REF 74035835 SIZE 6, CATALOG NUMBER: REF 74035836 SIZE 7, CATALOG NUMBER: REF 74035837 SIZE 8, CATALOG NUMBER: REF 74035838 SIZE 9, CATALOG NUMBER: REF 74035839 SIZE 10, CATALOG NUMBER: REF 74035840
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.
Identifiers
| code_info | SIZE 1, CATALOG NUMBER: REF 74035831; LOT/BATCH CODES: 19FM01064R, 19HM18082, 19HM21871, 19JM18534, 19JM21086, 19KM072…SIZE 1, CATALOG NUMBER: REF 74035831; LOT/BATCH CODES: 19FM01064R, 19HM18082, 19HM21871, 19JM18534, 19JM21086, 19KM07281, 19KM15577 SIZE 2, CATALOG NUMBER: REF 74035832; LOT/BATCH CODES: 19EM21587R, 19FM11181R, 19HM21899, 19HM21902, 19HM21903, 19JM21089 SIZE 3, CATALOG NUMBER: REF 74035833; LOT/BATCH CODES: 19GM21768, 19HM18085, 19HM18085A, 19JM09477, 19JM18537, 19JM18540, 19JM18541, 19JM18542, 19JM18542A SIZE 4, CATALOG NUMBER: REF 74035834; LOT/BATCH CODES: 19FM11183R, 19JM07474, 19JM11137, 19JM21090, 19KM21513 SIZE 5, CATALOG NUMBER: REF 74035835; LOT/BATCH CODES: 19FM01065R, 19HM18086, 19HM18086A, 19HM18088, 19JM18491, 19JM21091, 19KM15580 SIZE 6, CATALOG NUMBER: REF 74035836; LOT/BATCH CODES: 19FM11184R, 19GM21778, 19JM07477, 19JM21093 SIZE 7, CATALOG NUMBER: REF 74035837; LOT/BATCH CODES: 19FM11185A, 19FM11185R, 19HM19006, 19JM21096, 19KM21504, 19KM21506, 19KM21509 SIZE 8, CATALOG NUMBER: REF 74035838; LOT/BATCH CODES: 19FM11191R, 19FM11191S, 19HM1809 |
|---|
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-2133-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.