Recalls / —

—#42863

Product

TLC Self -Retaining Retractor System-5/box Product Number:820-176

FDA product code

GAD — Retractor

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

All lot codes

Why it was recalled

Sterility of device compromised due to breach in packaging

Root cause (FDA determination)

Other

Action the firm took

Boston Scientific initiated the recall on October 25, 2005 to accouunts requesting the return of the product and completion of the Reply Verification Tracking Form.

Recalling firm

Firm

Boston Scientific Corporation

Address

1 Boston Scientific Pl, Natick, Massachusetts 01760-1536

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2005-10-25

Posted by FDA

2005-12-01

Terminated

2007-06-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #42863. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.