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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 Retractorssee related information
Date Initiated by FirmOctober 06, 2004
Date PostedNovember 28, 2006
Recall Status1 Terminated 3 on December 22, 2006
Recall NumberZ-0213-2007
Recall Event ID 36592
Product Classification Retractors - Product Code GAD
ProductLone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1107; manufactured by Lone Star Medical Products, Inc.
Code Information Lot #5869 (Serial numbers: 5193 thru 5200, 5207 thru 5211 and 5213 thru 5229); Lot #5924 (Serial numbers: 5244, 5245, 5254, 5256 thru 5260, 5169, 5172, 5181, 5152, and 5185 thru 5187); & Lot #5982 (Serial numbers: 5148, 5176, 5183, 5184, 5188, 5192, 5204, 5206, 5253 and 5255).  Serial numbers: , ;
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
ActionFor 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 Commerce55 units.
DistributionWorld 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 CycleTPLC 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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