Recall Z-0843-2016— Zimmer Biomet, Inc.

Name: FDA recall Z-0843-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-11

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2016-01-11, terminated 2017-05-23. It names one FDA 510(k) clearance: K030265. Product: CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes 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.". Reason: LDPE bag containing the implant adheres to the highly polished implant surface..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-01-11
Terminated: 2017-05-23
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K030265 — CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00Zimmer, Inc.·cleared 2003-03-04

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 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes 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."

Reason for recall

LDPE bag containing the implant adheres to the highly polished implant surface.

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