Z-1842-2014Class II

VerSys Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581

Name: Z-1842-2014 VerSys Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581
Creator: Zimmer, Inc.
Published: 2014-05-19
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-05-19 / Terminated / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of VerSys Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581 on 2014-05-19. FDA classified it as Class II and gives the reason as "During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem, material requirements per ATS #14-04818 and ATS #14-05549, respectively". 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-1842-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-19
Posted: 2014-06-20
Terminated: 2015-03-24
Recalling firm: Zimmer GmbH
Product: VerSys Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem, material requirements per ATS #14-04818 and ATS #14-05549, respectively.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 6/2/2014 the firm sent "Urgent Medical Device Recall" letters to their customers. On 8/13/14, Zimmer contacted a distributor via phone pertaining to one additional lot (00-7843-011-06; lot 62547211) which had been included in the recall. Formal recall notices were issued to the distributor via email on 8/15/14.
Quantity in commerce: 147 units
Distribution: Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, MA, MI, MN, NC, ND, NJ, NY, OH, OK, PA, TN, TX, VA & WI, and the countries of Canada, Colombia, Dominican Republic, Japan, Korea (S. Korea), Peru, Taiwan & Thailand.
Product codes and lots: Item # 784301108, Lot #'s: 62478967, 62479742, 62503408, 62528282, 62530786, 62544915, 62554360; Item # 784301126, Lot #: 62544885, 62547211, Item # 784301156, Lot #, 62587079; Item # 784301208, Lot #'s: 62503411, 62509385, 62530790, 62547217, 62554362; Item # 784301226, Lot #'s: 62515502, 62547216; Item # 784301256, Lot #'s: 62489572, 62522386; Item # 784301326, Lot #, 62496464, 62594428, 62622893; Item # 784301356, Lot #: 62622894; Item # 784301382, Lot #: 62544907; Item # 784301511, Lot #: 62472423 & Item # 784301581, Lot #: 62496469.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1842-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1842-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-20

Product code LPH

K973714Class IIVersys Hip System Beaded Hip ProsthesisZimmer, Inc. / cleared 1997-12-24

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)