JOURNEY II UNI RESECTION PREP TRIAL — Class II medical device recall Z-2132-2020
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-2132-2020 |
|---|---|
| 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 | 200 units |
| Lot numbers | 19EM14365R, 19EM14365S, 19EM14367R, 19EM14371R, 19EM14372R, 19EM19112R, 19EM21573R, 19EM21573S, 19EM21578R, 19EM21582R, 19EM24480R, 19EM24498R, 19EM24498S, 19FM01063R, 19FM05587R, 19FM05589R, 19FM05591R, 19FM11173, 19FM11174R, 19FM11177R, 19FM11178R, 19FM11178S, 19FM11179R, 19FM11180, 19GM21787, 19HM18075, 19HM18078, 19HM18079, 19HM18080, 19HM18254, 19HM18335, 19HM19009, 19HM19648, 19HM19659, 19HM21015, 19HM21016, 19HM21031, 19HM21033, 19HM21855, 19HM21856 and 31 more |
| Model numbers | 74035821, 74035822, 74035823, 74035824, 74035825, 74035826, 74035827, 74035828, 74035829, 74035830 |
Product
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 NUMBER: REF 74035822 SIZE 3, CATALOG NUMBER: REF 74035823 SIZE 4, CATALOG NUMBER: REF 74035824 SIZE 5, CATALOG NUMBER: REF 74035825 SIZE 6, CATALOG NUMBER: REF 74035826 SIZE 7, CATALOG NUMBER: REF 74035827 SIZE 8, CATALOG NUMBER: REF 74035828 SIZE 9, CATALOG NUMBER: REF 74035829 SIZE 10, CATALOG NUMBER: REF 74035830
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-2132-2020. 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.