Date Initiated by Firm |
August 26, 2004 |
Date Posted |
October 23, 2004 |
Recall Status1 |
Terminated 3 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. |
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 2 |
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
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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 and Original Applicant = AMERICAN STERILIZER CO. 510(K)s with Product Code = HRX and Original Applicant = LINVATEC CORP.
|