Home / Recalls / Zimmer Biomet, Inc. / Z-0850-2016

Z-0850-2016 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

FDA device recall Z-0850-2016 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: 194.

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: 194

Product Description

Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (IJD) e.g. rheumatoid arthritis if bone quality is adequate. Failed previous surgery where pain, deformity, or dysfunction persists. Revision of previously failed hip arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely handicapped patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives. The system is intended for use either with or without bone cement in total hip arthroplasty."

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 number: 00-8770-040-02 Lots: 2564467 2573371 2625382 2631721 2655075 2655076 2685143

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0850-2016
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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