FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc: Tibial Base Plates
- Recall number
- Z-0305-05
- Recalling firm
- Smith & Nephew Inc
- Product
- Tibial Base Plates
- Status
- Terminated
- Initiated
- 2004-06-21
- Posted
- 2004-12-14
- Terminated
- 2006-02-15
- Reason
- The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.
- Root cause
- Other
- Action
- Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email) on 06/21/2004 to request the return of any in stock product.
- Quantity
- 11,339 units were distributed
- Distribution
- Nationwide, 43 consignees, 17 countries: Germany, France, Australia, Italy, Switzerland, United Arab Emirates, Belgium, Japan, United Kingdom, Singapore, Spain, Taiwan. Sweden, Canada Venezuela, South Africa, and Israel.
- Lot, serial or model codes
- Tibial Base Plates 726100, 726101, 727100, 727101, 726202, 726203, 727202, 727203, 726304, 726305, 727304, 727305
- 510(k) numbers
- ["K912735"]
- PMA numbers
- not on file
- Product code
- KRO
- 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