Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1104; manufactured by Lone Star Medical Pr

FDA device recall Z-0212-2007 · posted 2006-11-28 · Terminated

Recall details

Recalling firm

Lone Star Medical Products, Inc

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

GAD

Quantity affected

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.

Date initiated

2004-10-06

Date posted

2006-11-28

Date terminated

2006-12-22

Location

Stafford, TX