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Terminated

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

FDA Recall Z-0415-2009 · Posted 2008-11-28

Recalling FirmBiomet Microfixation, Inc.
Recall StatusTerminated
Product CodeFDG
Date Initiated2008-10-24
Date Terminated2009-09-11
Product Quantity3

Reason for Recall

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

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

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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