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Class 2 Device Recall JOURNEY II UNI |
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Date Initiated by Firm |
March 27, 2023 |
Date Posted |
April 14, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1393-2023 |
Recall Event ID |
91974 |
510(K)Number |
K190085
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Product Classification |
Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer - Product Code HSX
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Product |
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM |
Code Information |
Catalog Number: 74026178; UDI/DI: 00885556677209; Batch Number: 22CAP0038R; Lot Number: 22CAP0038R |
Recalling Firm/ Manufacturer |
Smith & Nephew, Inc. 1450 E Brooks Rd Memphis TN 38116-1804
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For Additional Information Contact |
David Snyder 978-749-1440
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Manufacturer Reason for Recall |
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.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Smith & Nephew notified consignees via email and overnight mail on 03/27/2023. Consignees were instructed to immediately review inventory and quarantine any affected units, notify customers if the product was further distributed, complete and return the response form and arrange for the return of affected units. |
Quantity in Commerce |
12 units |
Distribution |
US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = HSX and Original Applicant = Smith & Nephew Inc
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