Z-0097-2008

Foundation Hip System Bipolar Modular, Size 56mm OD; Cat. #412-01-056; Sterile; assembly required by...

Name: Z-0097-2008 Foundation Hip System Bipolar Modular, Size 56mm OD; Cat. #412-01-056; Sterile; assembly required by...
Creator: Encore Medical, Lp
Published: 2007-08-02
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2007-08-02 / Terminated / root cause: packaging

FDA source

Encore Medical, Lp began a recall of Foundation Hip System Bipolar Modular, Size 56mm OD; Cat. #412-01-056; Sterile; assembly required by physician prior to implant; manufactured by Encore... on 2007-08-02. The reason FDA records is "Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date". 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-0097-2008
Status: Terminated
Initiated: 2007-08-02
Posted: 2007-11-07
Terminated: 2008-01-09
Recalling firm: Encore Medical, LP
Product: Foundation Hip System Bipolar Modular, Size 56mm OD; Cat. #412-01-056; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Product code: KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Reason for recall: Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
Quantity in commerce: 86 units.
Distribution: Worldwide, including USA, Greece, Japan, and Saudi Arabia.
Product codes and lots: Lot #: 627751, 629111, 678981, 678991, 679001, 690231, 210192, 695841, 855041, 875561, 882671, 894381, 905671, 9072291, 939741, 949611 and 964521.

Product code KWY

K953510Class IIHip Joint Femoral (Hemi-Hip) Metal/polymer Cemented or Uncemented ProsthesisEncore Orthopedics, Inc. / cleared 1995-08-09

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)