Recall Z-0608-2014— Zimmer, Inc.

Name: FDA recall Z-0608-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-10

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2013-12-10, terminated 2014-09-11. It names 2 FDA 510(k) clearances: K960658, K913649. Product: 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: 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.
Classification: Class II
Status: Terminated
Initiated: 2013-12-10
Terminated: 2014-09-11
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K960658 — COLLARLESS POLISHED TAPER HIP PROSTHESISZimmer, Inc.·cleared 1996-07-16
K913649 — MODULAR CALCAR REPLACEMENTZimmer, Inc.·cleared 1991-11-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.