Recalls / —

—#34580

Product

Tibial Base Plates

FDA product code

KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K912735

Affected lot / code info

Tibial Base Plates 726100, 726101, 727100, 727101, 726202, 726203, 727202, 727203, 726304, 726305, 727304, 727305

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 #34580. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.