Home / Recalls / Zimmer Biomet, Inc. / Z-0843-2016

Z-0843-2016 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

FDA device recall Z-0843-2016 was initiated by Zimmer Biomet, Inc. on Jan 11, 2016 and is designated Class II. Reason for recall: LDPE bag containing the implant adheres to the highly polished implant surface. The recall status is terminated (terminated May 23, 2017). Affected quantity: 289.

Recall Details

Product Type: Devices
Report Date: Mar 2, 2016
Initiation Date: Jan 11, 2016
Termination Date: May 23, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 289

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.

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

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0843-2016
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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