—#34579

Product

Genesis Uni Articular Inserts

FDA product code: HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K912735
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew Inc
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2004-06-21
Posted by FDA: 2004-12-14
Terminated: 2006-02-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34579. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.