Class 2 Device Recall

• Date Initiated by Firm: August 26, 2004
• Date Posted: October 23, 2004
• Recall Status: Terminated on July 06, 2012
• Recall Number: Z-0041-05
• Recall Event ID: 29916
• 510(K)Number: K781979 K981636
• Product Classification: Arthroscope - Product Code HRX
• Product: Ultra Power Burs, Sterile, Single-Use.
• Code Information: All product with an expiration date between August 2004 and August 2009.
• FEI Number: 1017294
• Recalling Firm/ Manufacturer: Linvatec Corp.; 11311 Concept Blvd; Largo FL 33773-4908
• Manufacturer Reason for Recall: The pouch containing the sterile product is not completely seal on all products. Therefore , the sterility of the device is questionable.
• FDA Determined Cause: Packaging process control
• Action: Each consignee will be notified by telephone, email, letter or UPS overnight delivery. They will be asked to return the affected product to Linvatec, Largo, Florida for credit or no-cost replacement. A returned goods authorization number will be assigned for the returned product.
• Quantity in Commerce: 58510 units
• Distribution: Distributed to 492 customers throughout the United States, and 301 customers internationally.
• 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.

• 510(K) Database: 510(K)s with Product Code = HRX; 510(K)s with Product Code = HRX