Z-1064-2007

ALFA II Modular Femoral Stem Pourous Coated; Size 7; Length 200mm; Distal Diameter: 19.5mm; Catalog...

Name: Z-1064-2007 ALFA II Modular Femoral Stem Pourous Coated; Size 7; Length 200mm; Distal Diameter: 19.5mm; Catalog...
Creator: Encore Medical, Lp
Published: 2007-04-12
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2007-04-12 / Terminated / root cause: packaging

FDA source

Encore Medical, Lp began a recall of ALFA II Modular Femoral Stem Pourous Coated; Size 7; Length 200mm; Distal Diameter: 19.5mm; Catalog #651-07-195; component of the ENCORE Hip System; Single... on 2007-04-12. The reason FDA records is "Sterility/Package Integrity : Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1064-2007
Status: Terminated
Initiated: 2007-04-12
Posted: 2007-07-23
Terminated: 2007-07-25
Recalling firm: Encore Medical, LP
Product: ALFA II Modular Femoral Stem Pourous Coated; Size 7; Length 200mm; Distal Diameter: 19.5mm; Catalog #651-07-195; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical, L.P., Austin, TX 78758.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Sterility/Package Integrity : Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.
Root cause tag: packaging
FDA root cause: Other
Action: Urgent Device Recall Notification letters distributed to consignees on 04/14/07. Consignees requested to return product to Encore Medical, L.P.
Quantity in commerce: 3 units.
Distribution: Product distributed to surgical centers in CT, KS and MO.
Product codes and lots: Lot #Y032E and 2770.

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