Recalls / —

—#28175

Product

ProVision Hytrel Elastomer Hood; product 5431-05-000.

FDA product code

FYA — Gown, Surgical

Device class

Class 2

Medical specialty

General, Plastic Surgery

510(k) numbers

K972832

Affected lot / code info

All product manufactured between February 1, 2002 and June 17, 2003 that does not have a green square on the label above the CE mark. Product bearing the green square on the label has been 100% inspected and is not under recall.

Why it was recalled

Lack of assurance of sterility, due to the possibility of an incomplete package seal.

Root cause (FDA determination)

Other

Action the firm took

An Urgent Recall Notice was sent to customers on June 27, 2003 via federal express. Customers were instructed to locate all affected inventory and to immediately return it to Depuy.

Recalling firm

Firm

Depuy Orthopaedics, Inc.

Address

700 Orthopaedic Drive, Warsaw, Indiana 46581

Distribution

Distribution pattern

United States, Australia, Canada, Chile, England, India, Japan, Malaysia, Singapore, South Africa, Taiwan and United Kingdom

Timeline

Recall initiated

2003-06-27

Posted by FDA

2003-07-23

Terminated

2004-02-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #28175. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.