Z-0850-2016Class II

Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint...

Name: Z-0850-2016 Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint...
Creator: Zimmer Biomet, Inc.
Published: 2016-01-11
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-01-11 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis... on 2016-01-11. FDA classified it as Class II and gives the reason as "LDPE bag containing the implant adheres to the highly polished implant surface". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0850-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-11
Posted: 2016-02-22
Terminated: 2017-05-23
Recalling firm: Zimmer GmbH
Product: 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."
Product code: KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Reason for recall: LDPE bag containing the implant adheres to the highly polished implant surface.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zimmer Biomet sent an Urgent Medical Device Recall dated January 11, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with questions or concerns were instructed to contact customer service at 1-800-348-2759 or contact their Zimmer Biomet Sales Representative. For questions regarding this recall call 800-447-5633.
Quantity in commerce: 194
Distribution: 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
Product codes and lots: Item number: 00-8770-040-02 Lots: 2564467 2573371 2625382 2631721 2655075 2655076 2685143

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0850-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0830-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22
Z-0831-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22
Z-0832-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22
Z-0833-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22
Z-0834-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22
Z-0835-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22
Z-0836-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22
Z-0837-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22
Z-0838-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22
Z-0839-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22
Z-0840-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22
Z-0841-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22
Z-0842-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22
Z-0843-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22
Z-0844-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22
Z-0845-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22
Z-0846-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22
Z-0847-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22
Z-0848-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22
Z-0849-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22
Z-0850-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22

Product code KWA

K091973Class IIIMetasul Taper Liners, Metasul Femoral HeadsZimmer GmbH / cleared 2009-11-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)