Recall Z-0415-2009 ยท FDG Retractor, Fiberoptic
Biomet Microfixation, Inc.
Fredrick's Converse Retractor #5 F/O, Model Number: 01-0485. A fiber optic retractor used in plastic surgery procedures to retract tissue.
| Date | Nov 28, 2008 (initiated Oct 24, 2008) |
| Status | Terminated |
| Reason | Fiber optic cable is missing from the Frederick's Converse Retractor Lot # 042408D08. |
| Root cause | Nonconforming Material/Component |
| Action | Consignee was notified by certified mail via an Urgent Medical Device Recall Notice dated 10/24/08, with return receipt. The letter identifies the product and states the issue with the product. The letter required the customer to discontinue use of the item and return it to Biomet Microfixation so that they may rework the instrument. It also asked the customer to notify any hospital personnel responsible for receiving recall notices of this action if the product had been further distributed. The RGA number should be utilized to return the products. The Inventory Reconciliation sheet shoul |
| Quantity | 3 |
| Distribution | Nationwide Distribution --- including states of Chicago, IL and La Crosse, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.