Z-1128-04

HA Hip Stem, cementless

Name: Z-1128-04 HA Hip Stem, cementless
Creator: Encore Medical, Lp
Published: 2004-06-30
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2004-06-30 / Terminated / root cause: labeling and UDI

FDA source

Encore Medical, Lp began a recall of HA Hip Stem, cementless on 2004-06-30. The reason FDA records is "Hip stem product was mis-labeled with wrong size". 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-1128-04
Status: Terminated
Initiated: 2004-06-30
Posted: 2004-07-22
Terminated: 2004-10-21
Recalling firm: Encore Medical, LP
Product: HA Hip Stem, cementless
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Hip stem product was mis-labeled with wrong size.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Firm sent letter of notification to consignee on 6/30/2004.
Quantity in commerce: 3 units
Distribution: Deerfield Beach, FL
Product codes and lots: Part number 470-02-090, Lot 938381

Product code JDI

K993943Class IIEncore Linear Porous Coated Hip with Ha, Encore Foundation Porous Hip with Ha, Encore Revelation Porous Hip with HaEncore Orthopedics, Inc. / cleared 2000-02-04

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