Z-0213-2007

Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1107; manufactured by Lone Star...

Name: Z-0213-2007 Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1107; manufactured by Lone Star...
Creator: Lone Star Medical Products, Inc
Published: 2004-10-06
License: https://open.fda.gov/license/

Lone Star Medical Products / initiated 2004-10-06 / Terminated

FDA source

Lone Star Medical Products, Inc began a recall of Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1107; manufactured by Lone Star Medical Products, Inc on 2004-10-06. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0213-2007
Status: Terminated
Initiated: 2004-10-06
Posted: 2006-11-28
Terminated: 2006-12-22
Recalling firm: Lone Star Medical Products
Product: Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1107; manufactured by Lone Star Medical Products, Inc.
Product code: GAD Retractor
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 root cause: 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: 55 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.
Product codes and lots: 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: , ;

Product code GAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)