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Class 2 Device Recall Genesis II |
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Date Initiated by Firm |
June 27, 2022 |
Create Date |
July 20, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1418-2022 |
Recall Event ID |
90547 |
510(K)Number |
K951987
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Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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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. |
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 |
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.
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FDA Determined Cause 2 |
Process control |
Action |
The 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 Commerce |
31 devices |
Distribution |
US 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 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 = JWH and Original Applicant = SMITH & NEPHEW RICHARDS, INC.
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