Recalling Firm / Manufacturer

The Anspach Effort, Inc

Product

Anspach Single Use, Sterile Bone Cutting Burrs

Code Information

All cutting burrs packaged with an expiration date between June 2008 and august 2011

Reason of Recall

The white film portion of the sterile pouch may become brittle prior to the expiry date compromising the sterility of the product

Date Recall Initiated

May 18, 2007

Action

The firm issued a recall letter on May 18, 2007, to its consignee, advising them of the recall. Consignees were asked to screen their inventory for the recalled devices and complete an accompanying product replacement form. The firm will replace all returned product within 30 days. Firm Initiated recall is ongoing

Contact

Al-Nozha Medical Est.
Jeddah
(02) 6534664

Source of Information

U.S. FDA

SFDA Comments

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