Recall Z-0212-2007 ยท GAD Retractor
Lone Star Medical Products, Inc
Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1104; manufactured by Lone Star Medical Products, Inc.
| Date | Nov 28, 2006 (initiated Oct 6, 2004) |
| Status | Terminated |
| Reason | 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. |
| 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 repla |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.