Vortech Graft Preparation System, sterile, single use, disposable, Distributed by Biomet Biologics, Inc., Warsaw, Indiana; REF 800-0300V. (Not sold in the United States).
FDA Recall Z-0994-2007 · Posted 2007-07-04
Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeFMF
Date Initiated2007-06-11
Date Terminated2007-12-05
Product Quantity5 to Europe
Reason for Recall
The syringe assembly has an obstruction in the tube that prevents the plunger from being depressed.
Firm Action
Consignees were notified by letter dated either 6/11/07 or 6/13/07 and requested to return the product.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Chile, Italy, Spain and United Kingdom.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.