Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by defi ciencies of the femoral head, neck, or portions of the proximal femur. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief and when there is progressive disability.

Reason: Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct.

Code information: Part 00-7871-001-10 Lot 62359872

Distribution pattern: Worldwide Distribution -USA including OH, FL, WI, MI NJ, SC, CA, NC, PA, OR, WA, TN, KY, OK, KS, AZ, TX, CO, NV and Internationally to Germany. There have been 71 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf. 7 units have been returned, including three through the complaint process, which leaves 64 affected units in the field subject to removal.