Biomet, Inc.


   04 رجب 1428 هـ الموافق 18 يوليو 2007 م


Recalling Firm / Manufacturer

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).

Code Information

Lot 192380, exp. Jan 2012.

Reason of Recall

The syringe assembly has an obstruction in the tube that prevents the plunger from being depressed.

Date Recall Initiated

June 11, 2007

Action

Consignees were notified by letter dated either 6/11/07 or 6/13/07 and requested to return the product. Firm Initiated recall is ongoing.

Contact

Al-Amin Medical Co.
02 / 6601149

Source of Information

U.S. FDA

 

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.