CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained...
FDA Recall #Z-0608-2014 — Class II — December 10, 2013
Product Description
CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis. The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures. 510(k) K960658
Reason for Recall
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.
Recalling Firm
Zimmer, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
36
Distribution
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.
Code Information
Part 00-8114-002-10, Lot 62424414 Part 00-8011-004-00, Lot 62406423
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated