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U.S. Department of Health and Human Services

Class 2 Device Recall Genesis II

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 Class 2 Device Recall Genesis IIsee related information
Date Initiated by FirmJune 27, 2022
Create DateJuly 20, 2022
Recall Status1 Terminated 3 on March 25, 2026
Recall NumberZ-1418-2022
Recall Event ID 90547
510(K)NumberK951987 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
Code Information Product #71420186 - Lot #21DM14954S, exp. October 2030, UDI #03596010206350. Product #71420166 - Lot #21FM13870A, exp. October 2030, UDI #03596010206268.
FEI Number 1020279
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information ContactDavid Snyder
978-749-1440
Manufacturer Reason
for Recall		The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.
FDA Determined
Cause 2		Process control
ActionThe recalling firm issued letters dated 6/27/2022 via email and overnight mail on 6/27/2022. The letter described the issue, product details, shipment dates, potential risk of use of the product, and said that the required actions could be found on the attached response form. The response form was flagged that all items are to be completed and the form is to be returned within 5 days of receipt. The required actions instructed the consignee to inspect their inventory and quarantine the affected product. If the consignee is a sales rep, district office, or a distributor, they must notify their customers of the field action and ensure the required actions are complete. If there is no product to return, they are to check the appropriate box to indicate no product is being returned. If there is product to return, they are to complete the form and list the product part number, batches, and quantities they are returning. By signing the form, they are confirming their organization is aware of the field action and it has been communicated throughout the organization.
Quantity in Commerce31 devices
DistributionUS Nationwide distribution in the states of AZ, CA, GA, KS, LA, MN, MI, MO, MS, NC, NJ, NY, OR, SC, TN, VA, WA, and WI.
Total Product Life CycleTPLC Device Report
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JWH
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