FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
- Recall number
- Z-2883-2018
- Recalling firm
- Smith & Nephew, Inc.
- Product
- GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
- Status
- Terminated
- Initiated
- 2017-08-01
- Posted
- not on file
- Terminated
- 2019-02-19
- Reason
- Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.
- Root cause
- Employee error
- Action
- The firm notified its consignees of the problem and the recall by email on 08/01/2018. The firm requested the return of the product.
- Quantity
- 27 units
- Distribution
- Australia, Austria, Germany, Great Britain, Poland, Spain
- Lot, serial or model codes
- Lot Numbers: 16CMB0061A, 16CMB0066A
- 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