FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
- Recall number
- Z-1418-2022
- Recalling firm
- Smith & Nephew, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2022-06-27
- Posted
- not on file
- Terminated
- 2026-03-25
- Reason
- 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.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- Product #71420186 - Lot #21DM14954S, exp. October 2030, UDI #03596010206350. Product #71420166 - Lot #21FM13870A, exp. October 2030, UDI #03596010206268.
- 510(k) numbers
- ["K951987"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1020279
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28