—#100485

Product

Smith & Nephew Hip Arthroscopy Repair Instrument Tray Part Number: 72202732 Device Description-The Smith & Nephew Hip Arthroscopy Repair Instrument Tray is designed to contain and protect reusable surgical instruments during transport, sterilization, and storage and to allow optimal exposure of the tray's contents to sterilant during the sterilization process. The instrument tray is a perforated stainless steel case with a latchable lid and handle. The tray is fitted with nylon coated aluminum holders, silicone instrument holders, and a protective mat. The instrument tray is marked to facilitate organized instrument placement.

FDA product code: KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K102544
Affected lot / code info: Lot Number: 48208-1-1B

Why it was recalled

Hip Arthroscopy Repair Instrument Tray shipped with an incorrect Instructions For Use (IFU)

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Smith & Nephew sent an "URGENT FIELD CORRECTION NOTIFICATION" letter dated May 19, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers were instructed to confirm receipt of the corrected IFU document (10600729 rev B.) and communicate to appropriate facility individuals. Once appropriate individuals are informed, customers were instructed to complete and return information requested at the bottom of the letter. The completed information should be returned to Smith& Nephew via fax at 978-749-1654 or by mail at Smith & Nephew Endoscopy, 150 Minuteman Road, Andover, MA 01810. Questions may be answered by contacting the Manager, QA and Compliance at 978-749-1397.

Recalling firm

Firm: Smith & Nephew, Inc. Endoscopy Division
Address: 150 Minuteman Drive, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern: Worldwide Distribution--No USA Distribution; countries of Italy, Portugal, United Kingdom, and Venezuela.

Timeline

Recall initiated: 2011-05-19
Posted by FDA: 2011-06-24
Terminated: 2012-05-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #100485. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.