🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: January 28, 2020 Smith & Nephew Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Smith & Nephew, Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2132-2020

Related Recalls

META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690

Smith & Nephew

Class I - Dangerous

Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.

Mar 18, 2025 Other Medical Devices Nationwide View Details →