Recalls / —

—#34102

Product

Achillon minimally invasive Achilles tendon suture system

FDA product code

MCZ — Suture Removal Kit

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Product: Achillon Reference No.: 119 700  Batch No.: C Sterilization Batch No.: S037

Why it was recalled

Lack of sterility assurance

Root cause (FDA determination)

Other

Action the firm took

Wright Medical Technology notified its consignees via email and telephone to ensure that the email was received. The consignees asked to return any in-stock recalled product to Wright Medical Technology.

Recalling firm

Firm

Wright Medical Technology Inc

Address

5677 Airline Road P.O. Box 100, Arlington, Tennessee 38002-0100

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2004-07-02

Posted by FDA

2004-07-31

Terminated

2005-07-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #34102. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.