Z-0415-2009

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

Name: Z-0415-2009 Fredrick's Converse Retractor #5 F/O, Model Number: 01-0485. A fiber optic retractor used in plastic surgery...
Creator: Biomet Microfixation, Inc.
Published: 2008-10-24
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2008-10-24 / Terminated / root cause: manufacturing process

FDA source

Biomet Microfixation, Inc. began a recall of Fredrick's Converse Retractor #5 F/O, Model Number: 01-0485. A fiber optic retractor used in plastic surgery procedures to retract tissue on 2008-10-24. The reason FDA records is "Fiber optic cable is missing from the Frederick's Converse Retractor Lot # 042408D08". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0415-2009
Status: Terminated
Initiated: 2008-10-24
Posted: 2008-11-28
Terminated: 2009-09-11
Recalling firm: Biomet Microfixation
Product: Fredrick's Converse Retractor #5 F/O, Model Number: 01-0485. A fiber optic retractor used in plastic surgery procedures to retract tissue.
Product code: FDG Retractor, Fiberoptic
Reason for recall: Fiber optic cable is missing from the Frederick's Converse Retractor Lot # 042408D08.
Root cause tag: manufacturing process
FDA 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 should be filled out and faxed to 904-741-9425.
Quantity in commerce: 3
Distribution: Nationwide Distribution --- including states of Chicago, IL and La Crosse, WI.
Product codes and lots: Lot # 042408D08

Product code FDG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)