Z-1468-06

Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 14, 135...

Name: Z-1468-06 Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 14, 135...
Creator: Zimmer Inc.
Published: 2006-08-02
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2006-08-02 / Terminated

FDA source

Zimmer Inc. began a recall of Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 14, 135 mm stem length, tivanium TI-6AL-4V alloy, sterile... on 2006-08-02. The reason FDA records is "Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1468-06
Status: Terminated
Initiated: 2006-08-02
Posted: 2006-08-31
Terminated: 2007-05-04
Recalling firm: Zimmer GmbH
Product: Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 14, 135 mm stem length, tivanium TI-6AL-4V alloy, sterile; Cat. no. 7861-14-04 (00786101404).
Product code: LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Reason for recall: Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.
FDA root cause: Other
Action: Consignees were notified via letter dated 8/2/06 to cease use of and to return the products. Zimmer distributors were to examine stock and return product on hand.
Quantity in commerce: 181 of all devices
Distribution: Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland.
Product codes and lots: Lots 60454196, 60454197, 60454198, 60454199, 60465016 and 60465017.

Product code LWJ

K961378Class IIDelta Hip ProsthesisZimmer, Inc. / cleared 1996-10-08

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)