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U.S. Department of Health and Human Services

Class 2 Device Recall 1100 Series Aluminum Retractors

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  Class 2 Device Recall 1100 Series Aluminum Retractors see related information
Date Initiated by Firm October 06, 2004
Date Posted November 28, 2006
Recall Status1 Terminated 3 on December 22, 2006
Recall Number Z-0212-2007
Recall Event ID 36592
Product Classification Retractors - Product Code GAD
Product Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1104; manufactured by Lone Star Medical Products, Inc.
Code Information Lot #6000 (Serial numbers: 1480 thru 1489); Lot #6058 (Serial numbers: 1490 thru 1493 and 1534 thru 1539); & Lot #6155 (Serial numbers: 1540 thru 1559).
Recalling Firm/
Manufacturer		 Lone Star Medical Products, Inc
11211 Cash Rd
Stafford TX 77477
Manufacturer Reason
for Recall		 Ni-Cr Plated 1100 Series Retractors with a chromium finish were replaced by Retractors with a hard-anodized finish after complaints of peeling were received.
FDA Determined
Cause 2		 Other
Action For domestic customers, the firm sent product replacement letters to customers (as listed on the firm's invoices), and hospital operating room personnel on October 6, 2004. On November 8, 2004, a faxed letter was sent to the Purchasing/Materials Management Department of all customers. From November 9 through November 12, 2004, a phone call drive was conducted to contact appropriate individuals for each customer. For international customers, the firm notified distributors and obtained end user details from them. End users were then contacted and communicated with regarding the product replacement. In addition, the firm utilized its Summer and Fall 2004 newsletters to communicate the product replacement information. Customers were encouraged to return NiCr coated products for a hard-anodized coated replacement product.
Quantity in Commerce 40 units.
Distribution World wide, including USA, Denmark, Germany, Finland, France, Taiwan, Canada, South Korea, New Zealand, Hong Kong, Italy, England, Australia, Saudi Arabia, South Africa and Singapore.
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.
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