Recalls / —

—#25125

Product

Smith & Nephew ACUFEX Rap-Pac ACL Accessory Kit, Sterile Catalog Number: 014725

FDA product code

HRX — Arthroscope

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K931621

Affected lot / code info

Lot Number: 552240

Why it was recalled

Potential for non sterility as package tray does not contain aeration holes for ETO processing.

Root cause (FDA determination)

Process control

Action the firm took

Smith & Nephew notified customers by letter on 11/8/02. Users are requested to remove stock and return to Smith & Nephew.

Recalling firm

Firm

Smith & Nephew, Inc.

Address

130 Forbes Boulevard, Mansfield, Massachusetts 02048

Distribution

Distribution pattern

Nationwide: AL, CA, IL, KY, FL, GA, IN, ME, MI, NH,NY, OH, SC, TX, WV,

Timeline

Recall initiated

2002-11-08

Posted by FDA

2003-01-09

Terminated

2005-04-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25125. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.