FDA Device

Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.

Hazard

The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.

What You Should Do

Remedy

Consignees were notified via letter dated August 23, 2005 or by email.