Zimmer Biomet, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0843-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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."

Product Classification:

Class II

Date Initiated: January 11, 2016

Date Posted: March 2, 2016

Recall Number: Z-0843-2016

Event ID: 73142

Reason for Recall:

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

Status: Terminated

Product Quantity: 289

Code Information:

Item numbers: 00-8114-040-00 00-8114-050-00 Lot numbers: 61790499 61878931 61891348 61907682 61993208 61993210 62030932 62038367 62106796 62106797 62148557 62161479 62206538

Distribution Pattern:

Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL ECUADOR EL SALVADOR ENGLAND FRANCE GERMANY GUATEMALA HONDURAS HONG KONG INDIA ISRAEL ITALY JAMAICA JAPAN KOREA MALAYSIA MEXICO NEW ZEALAND NICARAGUA PANAMA PERU SINGAPORE SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND VENEZUELA WEST INDIES Canary Islands Croatia Cyprus Czech Republic Canada

Voluntary or Mandated:

Voluntary: Firm initiated