Smith & Nephew JOURNEY II Uni Resection Prep Trial: Spike rail defect risks disassembly
Smith & Nephew recalls JOURNEY II Uni Resection Prep Trial surgical instruments with a spike rail that may disassemble due to an oversized thru-hole. Affected models include sizes 1-10 with specific lot codes.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Smith & Nephew is recalling JOURNEY II Uni Resection Prep Trial surgical instruments because a spike rail defect could cause the device to disassemble during use. This poses a risk of improper surgical fixation if the instrument fails. Read more at govinfonow.com/recall/65943-smith-nephew-journey-ii-uni-resection-prep-trial-spike-rail.
Source Summary by GovInfoNow · govinfonow.com/recall/65943-smith-nephew-journey-ii-uni-resection-prep-trial-spike-rail · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2132-2020
Cite this page
“Smith & Nephew JOURNEY II Uni Resection Prep Trial: Spike rail defect risks disassembly.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/65943-smith-nephew-journey-ii-uni-resection-prep-trial-spike-rail. Based on FDA recall #Z-2132-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2132-2020%22&limit=1).
Why it’s dangerous
The spike rail has an oversized thru-hole that can cause the dowel pin to fall out. This may lead to the device disassembling during surgery, potentially causing improper joint fixation and affecting surgical outcomes.
Who’s affected
Surgical professionals using the JOURNEY II Uni Resection Prep Trial instruments for joint surgery are most at risk. Patients undergoing procedures with these instruments may be affected if the device disassembles during surgery.
How to tell if you have this one
Check for the product name 'JOURNEY II Uni Resection Prep Trial' with sizes 1-10. Look for catalog numbers REF 74035821-30 and specific lot/batch codes listed in the recall notice.
- Brand
Smith & Nephew- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Nationwide distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2132-2020 | 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; SIZE 1, CATALOG NUMBER: REF 74035821; LOT/BATCH CODES: 19EM19112R, 19FM05587R, 19FM11174R, 19HM18075, 19HM19648, 19HM21015, 19HM21016, 19HM23242 SIZE 2, CATALOG NUMBER: REF 74035822; LOT/BATCH CODES: 19EM21573R, 19EM21573S, 19FM05589R, 19HM21031, 19HM21033, 19HM21878, 19HM21881 SIZE 3, CATALOG NUMBER: REF 74035823; LOT/BATCH CODES: 19EM21578R, 19HM19009, 19JM09476, 19JM18509, 19JM18525, 19JM21072, 19KM14473, 19KM17780 SIZE 4, CATALOG NUMBER: REF 74035824; LOT/BATCH CODES: 19EM14365R, 19EM14365S, 19FM11173, 19HM18078, 19HM19659, 19HM21861, 19JM21075, 19KM15573, 19KM1557 SIZE 5, CATALOG NUMBER: REF 74035825; LOT/BATCH CODES: 19EM14367R, 19HM18079, 19HM21855, 19KM12683 SIZE 6, CATALOG NUMBER: REF 74035826; LOT/BATCH CODES: 19EM24480R, 19HM18080, 19HM21856, 19KM21512 SIZE 7, CATALOG NUMBER: REF 74035827; LOT/BATCH CODES: 19EM14371R, 19FM01063R, 19FM11177R, 19HM18335, 19HM21873, 19HM21874, 19KM17781 SIZE 8, CATALOG NUMBER: REF 74035828; LOT/BATCH CODES: 19EM24498R, 19EM24498S, 19FM05591R, 19FM11178R, 19FM11178S, 19JM07464, 19JM07465, 19KM07278, 19KM12699 SIZE 9, CATALOG NUMBER: REF 74035829; LOT/BATCH CODES: 19EM21582R, 19FM11179R, 19GM21787, 19JM07467, 19KM07276, 19KM15575, 19KM15576 SIZE 10, CATALOG NUMBER: REF 74035830; LOT/BATCH CODES: 19EM14372R, 19FM11180, 19HM18254, 19JM07468, 19JM07470, 19JM07472, 19KM05610, 19KM15571 | 200 units |
| 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 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; 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, 19HM18091, 19HM21040, 19JM18543, 19JM21097, 19JM23714, 19KM15583 SIZE 9, CATALOG NUMBER: REF 74035839; LOT/BATCH CODES: 19FM05578R, 19HM18096, 19HM19658, 19KM05613, 19KM15584, 19KM15586 SIZE 10, CATALOG NUMBER: REF 74035840; LOT/BATCH CODES: 19HM18107, 19HM19004, 19JM23666, 19JM23674, 19JM23678, 19JM23678A, 19JM23680, 19KM12708 | 195 units |
What to do — step by step
Check Product Details
Identify the size, catalog number, and lot/batch code to confirm if your instrument is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall states the spike rail defect could cause disassembly during use, so it is not safe to use without checking if it's affected.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2132-2020 (January 28, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2132-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.