00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780303605 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

Reason: Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Intraoperative dislodging of the provisional head and the provisional head being left in-vivo after separating from mating comp

Code information: All lots including lot 78939000 (1/7/2002) to present

Distribution pattern: Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.