Z-1868-2008

Encore Modular Femoral Neck, 12 degree/35 mm; Ref #410-35-112; distributed by Encore Medical, Austin, TX...

Name: Z-1868-2008 Encore Modular Femoral Neck, 12 degree/35 mm; Ref #410-35-112; distributed by Encore Medical, Austin, TX...
Creator: Encore Medical, Lp
Published: 2008-05-08
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2008-05-08 / Terminated / root cause: manufacturing process

FDA source

Encore Medical, Lp began a recall of Encore Modular Femoral Neck, 12 degree/35 mm; Ref #410-35-112; distributed by Encore Medical, Austin, TX 78758. Designed to ensure the proper anteversion and... on 2008-05-08. The reason FDA records is "Product not manufactured to specifications; modular femoral necks found to contain 24 scallops, instead of the standard 12". 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-1868-2008
Status: Terminated
Initiated: 2008-05-08
Posted: 2008-08-26
Terminated: 2009-09-08
Recalling firm: Encore Medical, LP
Product: Encore Modular Femoral Neck, 12 degree/35 mm; Ref #410-35-112; distributed by Encore Medical, Austin, TX 78758. Designed to ensure the proper anteversion and femoral head orientation in the acetabulum.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Product not manufactured to specifications; modular femoral necks found to contain 24 scallops, instead of the standard 12.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Firm notified sales agents of recall on 05/08/08 via an Urgent: Medical Device Recall letter. Sales agents asked to immediately examine their inventory and quarantine product subject to recall. Agents are asked to notify their customers if they had further distributed the product. All product must be returned to Encore along with the response form.
Quantity in commerce: 20 units
Distribution: Worldwide Distribution --- USA including states of IN, KS, GA, WA, SD, and countries of Greece and Australia.
Product codes and lots: Lots #53876569, Exp 7/23/2013; 53869022, and lot 53873037

Product code JDI

K000817Class IIOmega II Modular Total Hip SystemOsteoimplant Technology, Inc. / cleared 2000-06-08

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)