FDA Medical Device Recalls (openFDA)
Biomet Microfixation, Inc.: Fredrick's Converse Retractor #5 F/O, Model Number: 01-0485. A fiber optic retractor used in plastic surgery procedures to retract tissue.
- Recall number
- Z-0415-2009
- Recalling firm
- Biomet Microfixation, Inc.
- Product
- Fredrick's Converse Retractor #5 F/O, Model Number: 01-0485. A fiber optic retractor used in plastic surgery procedures to retract tissue.
- Status
- Terminated
- Initiated
- 2008-10-24
- Posted
- 2008-11-28
- Terminated
- 2009-09-11
- Reason
- Fiber optic cable is missing from the Frederick's Converse Retractor Lot # 042408D08.
- 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
- 3
- Distribution
- Nationwide Distribution --- including states of Chicago, IL and La Crosse, WI.
- Lot, serial or model codes
- Lot # 042408D08
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FDG
- Firm FEI
- 1032347
- Firm city
- Jacksonville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28