Stelkast Co Proven Porous CR Femur. Implantable orthopedic device Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Sterility may be compromised. The inner pouch of the implant packaging was sticking out beyond the seal of the outer pouch

Recommended Action

Per FDA guidance

The recalling firm telephoned their customers 9/24/04 to inform them of the problem and the need to return the product. As a follow up to the telephone call, the recalling firm sent fax notifications to their customers. The medical supply companies were instructed to contact their customers.

Distribution

As reported by FDA

AZ, CA, IN, MO, NC, PA, WV