Journey II UNI Resection Prep Trial recall
JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT 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 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
- Product
- JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical…
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 195 units
- Distribution
- US Nationwide distribution.
- Recall date
- June 3, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)