Reported Jun 3, 2020 · Terminated
JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage
Smith & Nephew, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew, Inc. · 1450 E Brooks Rd · Memphis, TN · 38116-1804
Is this the product you have?
JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage
10 of 10 products
| Model / number | Product as published |
|---|---|
74035821 | SIZE 2, CATALOG NUMBER |
74035822 | SIZE 3, CATALOG NUMBER |
74035823 | SIZE 4, CATALOG NUMBER |
74035824 | SIZE 5, CATALOG NUMBER |
74035825 | SIZE 6, CATALOG NUMBER |
74035826 | SIZE 7, CATALOG NUMBER |
74035827 | SIZE 8, CATALOG NUMBER |
74035828 | SIZE 9, CATALOG NUMBER |
74035829 | SIZE 10, CATALOG NUMBER |
74035830 | — |
- Lot codes and dates
11 of 11 products
Products covered by this recall # Product as published 1 SIZE 1, CATALOG NUMBER: REF 74035821 2 LOT/BATCH CODES: 19EM19112R, 19FM05587R, 19FM11174R, 19HM18075, 19HM19648, 19HM21015, 19HM21016, 19HM23242 SIZE 2, CATALOG NUMBER: REF 74035822 3 LOT/BATCH CODES: 19EM21573R, 19EM21573S, 19FM05589R, 19HM21031, 19HM21033, 19HM21878, 19HM21881 SIZE 3, CATALOG NUMBER: REF 74035823 4 LOT/BATCH CODES: 19EM21578R, 19HM19009, 19JM09476, 19JM18509, 19JM18525, 19JM21072, 19KM14473, 19KM17780 SIZE 4, CATALOG NUMBER: REF 74035824 5 LOT/BATCH CODES: 19EM14365R, 19EM14365S, 19FM11173, 19HM18078, 19HM19659, 19HM21861, 19JM21075, 19KM15573, 19KM1557 SIZE 5, CATALOG NUMBER: REF 74035825 6 LOT/BATCH CODES: 19EM14367R, 19HM18079, 19HM21855, 19KM12683 SIZE 6, CATALOG NUMBER: REF 74035826 7 LOT/BATCH CODES: 19EM24480R, 19HM18080, 19HM21856, 19KM21512 SIZE 7, CATALOG NUMBER: REF 74035827 8 LOT/BATCH CODES: 19EM14371R, 19FM01063R, 19FM11177R, 19HM18335, 19HM21873, 19HM21874, 19KM17781 SIZE 8, CATALOG NUMBER: REF 74035828 9 LOT/BATCH CODES: 19EM24498R, 19EM24498S, 19FM05591R, 19FM11178R, 19FM11178S, 19JM07464, 19JM07465, 19KM07278, 19KM12699 SIZE 9, CATALOG NUMBER: REF 74035829 10 LOT/BATCH CODES: 19EM21582R, 19FM11179R, 19GM21787, 19JM07467, 19KM07276, 19KM15575, 19KM15576 SIZE 10, CATALOG NUMBER: REF 74035830 11 LOT/BATCH CODES: 19EM14372R, 19FM11180, 19HM18254, 19JM07468, 19JM07470, 19JM07472, 19KM05610, 19KM15571 - Amount recalled
- 200 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Smith & Nephew, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.