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Recall Observatory FDA recall evidence

Device product

JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM

Z-1393-2023

March 27, 2023

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 91974
Status
Ongoing
Classification
Class II
Quantity
12 units
Official record key
device-enforcement:Z-1393-2023

Official wording

Reason: A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.

Code information: Catalog Number: 74026178; UDI/DI: 00885556677209; Batch Number: 22CAP0038R; Lot Number: 22CAP0038R

Distribution pattern: US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.