JOURNEY II UNI RESECTION PREP TRIAL — Class II medical device recall Z-2133-2020
Terminated recall by Smith & Nephew, Inc., reported 2020-06-03, distributed nationwide. The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fal
| Recall number | Z-2133-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2020-01-28 |
| Classified | 2020-05-27 |
| Reported by FDA | 2020-06-03 |
| Terminated | 2023-12-11 |
| Distributed | Nationwide (US) |
| Quantity | 195 units |
| Lot numbers | 19EM21587R, 19FM01064R, 19FM01065R, 19FM05578R, 19FM11181R, 19FM11183R, 19FM11184R, 19FM11185A, 19FM11185R, 19FM11191R, 19FM11191S, 19GM21768, 19GM21778, 19HM18082, 19HM18085, 19HM18085A, 19HM18086, 19HM18086A, 19HM18088, 19HM18091, 19HM18096, 19HM18107, 19HM19004, 19HM19006, 19HM19658, 19HM21040, 19HM21871, 19HM21899, 19HM21902, 19HM21903, 19JM07474, 19JM07477, 19JM09477, 19JM11137, 19JM18491, 19JM18534, 19JM18537, 19JM18540, 19JM18541, 19JM18542 and 27 more |
| Model numbers | 74035831, 74035832, 74035833, 74035834, 74035835, 74035836, 74035837, 74035838, 74035839, 74035840 |
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 for recall
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.
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-2133-2020. 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.