FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc: Genesis Uni Articular Inserts
- Recall number
- Z-0304-05
- Recalling firm
- Smith & Nephew Inc
- Product
- Genesis Uni Articular Inserts
- 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
- Genesis Uni Articular Inserts 71248108, 71248109, 71248110, 71248111, 71248112, 71248208, 71248209, 71248210, 71248211, 71248212, 71248308, 71248309, 71248310, 71248311, 71248312, 71248228, 71248229, 71248230, 71248231, 71248232, 71248235, 71248328, 71248329, 71248330, 71248331, 71248332, 71248335, 71248338, 71248339, 71248340, 71248341, 71248342, 71248345 Sold internationally: 71975865, 71975866, 71975867, 71975870, 71975871, 71975872, 71975873
- 510(k) numbers
- ["K912735"]
- PMA numbers
- not on file
- Product code
- HSX
- 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