FDA Device

Genesis Uni Articular Inserts

Hazard

The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.

What You Should Do

Remedy

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.

Products

Genesis Uni Articular Inserts
Brand
Smith & Nephew Inc
UPC
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

Units Affected

11,339 units were distributed