FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Vortech Graft Preparation System, sterile, single use, disposable, Distributed by Biomet Biologics, Inc., Warsaw, Indiana; REF 800-0300V. (Not sold in the United States).
- Recall number
- Z-0994-2007
- Recalling firm
- Biomet, Inc.
- Product
- Vortech Graft Preparation System, sterile, single use, disposable, Distributed by Biomet Biologics, Inc., Warsaw, Indiana; REF 800-0300V. (Not sold in the United States).
- Status
- Terminated
- Initiated
- 2007-06-11
- Posted
- 2007-07-04
- Terminated
- 2007-12-05
- Reason
- The syringe assembly has an obstruction in the tube that prevents the plunger from being depressed.
- Root cause
- Other
- Action
- Consignees were notified by letter dated either 6/11/07 or 6/13/07 and requested to return the product.
- Quantity
- 5 to Europe
- Distribution
- Worldwide, including USA, Chile, Italy, Spain and United Kingdom.
- Lot, serial or model codes
- Lot 192380, exp. Jan 2012.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- 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