Recalls / —

—#54384

Product

Duracon Total Knee Modular Femoral Component; Non-Porous Right Medium Assembly, Product No. 6632-0-325

FDA product code

JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K920034

Affected lot / code info

Product No. 6632-0-325; Lot code UCVO

Why it was recalled

Loose fixation pegs: One lot of femoral components may have loose fixation pegs.

Root cause (FDA determination)

Other

Action the firm took

Notification letters, dated 10/17/2006, were sent via Federal Express on 10/17/2006 to all consignees requesting return of product.

Recalling firm

Firm

Stryker Howmedica Osteonics Corp.

Address

325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern

Worldwide : One Hospital in Georgia (USA), Stryker Branch in Indiana and Stryker Branch in Sweden.

Timeline

Recall initiated

2006-10-17

Posted by FDA

2007-09-21

Terminated

2009-07-07

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #54384. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.