Recall Z-0415-2009

Reason for recall

Fiber optic cable is missing from the Frederick's Converse Retractor Lot # 042408D08.

FDA-determined cause: Nonconforming Material/Component

Action taken

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 should be filled out and faxed to 904-741-9425.