Z-0304-05

Genesis Uni Articular Inserts

Name: Z-0304-05 Genesis Uni Articular Inserts
Creator: Smith & Nephew Inc
Published: 2004-06-21
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2004-06-21 / Terminated

FDA source

Smith & Nephew Inc began a recall of Genesis Uni Articular Inserts on 2004-06-21. The reason FDA records is "The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0304-05
Status: Terminated
Initiated: 2004-06-21
Posted: 2004-12-14
Terminated: 2006-02-15
Recalling firm: Smith & Nephew, Inc.
Product: Genesis Uni Articular Inserts
Product code: HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Reason for recall: The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.
FDA 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 in commerce: 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.
Product codes and lots: 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

Product code HSX

K912735Class IIGenesis Unicompartmental Knee SystemSmith & Nephew Richards, Inc. / cleared 1991-12-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)