Z-0846-2016Class II

VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip...

Name: Z-0846-2016 VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip...
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 VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and... 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-0846-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-11
Posted: 2016-02-22
Terminated: 2017-05-23
Recalling firm: Zimmer GmbH
Product: VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. " Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected."
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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: 130
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 numbers: 00-7843-011-16 00-7843-012-16 00-7843-013-16 00-7843-014-16 00-7843-015-16 00-7843-016-16 Lot numbers: 61760685 61781980 61840199 61844725 61844726 61951281 61956725 61968111 61987956 62011958 62029062 62034145 62097248 62097288 62120672

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0846-2016
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 LPH

K042776Class IIVersys Hip System Beaded Midcoat Low Head Center Hip Prosthesis, Model 00-7840-Xxx-XxZimmer, Inc. / cleared 2004-11-04

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)