Fredrick's Converse Retractor #5 F/O, Model Number: 01-0485. A fiber optic retractor used in plastic surgery procedures

FDA device recall Z-0415-2009 · posted 2008-11-28 · Terminated

Recall details

Recalling firm

Biomet Microfixation, Inc.

Reason for recall

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

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FDG

Quantity affected

3

Distribution

Nationwide Distribution --- including states of Chicago, IL and La Crosse, WI.

Date initiated

2008-10-24

Date posted

2008-11-28

Date terminated

2009-09-11

Location

Jacksonville, FL