Journey II UNI Resection Prep Trial recall
JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical…
Why was Journey II UNI Resection Prep Trial 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical…
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 200 units
- Distribution
- US Nationwide distribution.
- Recall date
- June 3, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)