Fredrick's Converse Retractor #5 F/O, Model Number: 01-0485. A fiber optic retractor used in plastic surgery procedures to retract tissue.
This recall has been terminated (originally issued November 28, 2008).
- Company
- Biomet Microfixation, Inc.
- Recall Initiated
- October 24, 2008
- Posted
- November 28, 2008
- Terminated
- September 11, 2009
- Recall Number
- Z-0415-2009
- Quantity
- 3
- Firm Location
- Jacksonville, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Fiber optic cable is missing from the Frederick's Converse Retractor Lot # 042408D08.
Distribution
Nationwide Distribution --- including states of Chicago, IL and La Crosse, WI.
Lot / Code Info
Lot # 042408D08
Root 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.