FDA Device

Distal Centralizer 10 mm

Hazard

The hip stem did not fit the distal centralizer because the hole was not drilled with the appropriate taper.

What You Should Do

Remedy

Ortho Development sent a Field Notification Memo dated July 28, 2010 to Japan Medical Dynamic Marketing instructing them to reconcile parts that may have been used and return unused parts to Ortho. Customers can contact Ortho Development at 1-801-619-3419.

Products

Distal Centralizer 10 mm
Brand
Ortho Development Corporation
UPC
Work order numbers: 0050794; 0051535; 0054967; 0055667; 0060372; 0061102; 0061769; 0062929; 0063395

Units Affected

39 units