Class 2 Device Recall ProWick Shoulder Postoperative Dressing and Cold Therapy System

• Date Initiated by Firm: February 01, 2007
• Date Posted: April 04, 2007
• Recall Status: Terminated on August 03, 2012
• Recall Number: Z-0714-2007
• Recall Event ID: 37358
• Product Classification: Postoperative Dressing and Cold Therapy System - Product Code FRO
• Product: ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625
• Code Information: Lot number: D632517
• FEI Number: 1000519289
• Recalling Firm/ Manufacturer: Integra Biotechnical LLC; 2755 Dos Aarons Way, Ste B; Vista CA 92081
• For Additional Information Contact: George W. Walker II; 760-597-9878
• Manufacturer Reason for Recall: During routine new product testing, it was discovered that the product may not be sterile, although sterilized in accordance with validated parameters.
• FDA Determined Cause: Other
• Action: An email and/or fax recall notification was sent starting on 02/1/2007 by Arthrex, Inc. (the Primary Distributor) . A product recall notice in the form of a letter was mailed via US Postal Certified Mail, return receipt requested by Arthrex, Inc. to all of the Distributor''s customers starting on 02/1/2007, including those who have not ordered or received the Recalled Product. Customers were asked to 'segregate and protect the product from shipment, and return all unused products to Arthrex, Inc.'
• Quantity in Commerce: 1769
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.