Z-1066-05

Zimmer brand Versys Hip System Femoral Head 12/14 taper, 32 mm dia., neck length +0mm; Product 00-8018-032-02

Name: Z-1066-05 Zimmer brand Versys Hip System Femoral Head 12/14 taper, 32 mm dia., neck length +0mm; Product 00-8018-032-02
Creator: Zimmer Inc.
Published: 2005-04-15
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2005-04-15 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Inc. began a recall of Zimmer brand Versys Hip System Femoral Head 12/14 taper, 32 mm dia., neck length +0mm; Product 00-8018-032-02 on 2005-04-15. The reason FDA records is "May be mislabeled as to dimensions; may be 12/14 taper, 28mm dia., neck length +3.5mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1066-05
Status: Terminated
Initiated: 2005-04-15
Posted: 2005-08-03
Terminated: 2005-08-11
Recalling firm: Zimmer GmbH
Product: Zimmer brand Versys Hip System Femoral Head 12/14 taper, 32 mm dia., neck length +0mm; Product 00-8018-032-02.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: May be mislabeled as to dimensions; may be 12/14 taper, 28mm dia., neck length +3.5mm.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified via certified letter dated 4/6/05.
Quantity in commerce: 38
Distribution: Nationwide and Canada.
Product codes and lots: Lot 60252787.

Product code JDI

K953337Class IIBeta Hip ProsthesisZimmer, Inc. / cleared 1996-01-22

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)