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.
This recall has been terminated (originally issued June 24, 2011).
- Recall Initiated
- May 19, 2011
- Posted
- June 24, 2011
- Terminated
- May 9, 2012
- Recall Number
- Z-2646-2011
- Quantity
- 11 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Hip Arthroscopy Repair Instrument Tray shipped with an incorrect Instructions For Use (IFU)
Distribution
Worldwide Distribution--No USA Distribution; countries of Italy, Portugal, United Kingdom, and Venezuela.
Lot / Code Info
Lot Number: 48208-1-1B
Root Cause
Labeling mix-ups
Action Taken
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.