Z-0648-2008

Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 54 mm, Hip Prosthesis Component, Stryker...

Name: Z-0648-2008 Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 54 mm, Hip Prosthesis Component, Stryker...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2007-10-26
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2007-10-26 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 54 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 on 2007-10-26. The reason FDA records is "Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head". 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-0648-2008
Status: Terminated
Initiated: 2007-10-26
Posted: 2008-03-20
Terminated: 2010-01-27
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 54 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Product code: KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Reason for recall: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stryker sent Urgent Product Hold letters to US branches/agencies and hospitals on October 26, 2007 advising them to quarantine the product from these lots, and Urgent Product Recall letters on November 2, 2007 advising them to return the devices to Stryker. International distributors were sent an advisory on November 6, 2007.
Quantity in commerce: 360 total
Distribution: Worldwide Distribution - USA, Canada, China, India, Australia, Korea, Singapore, Taiwan, Sweden, Germany, Netherlands, France, Spain, Italy, Poland, South Africa, and England.
Product codes and lots: Ref No: Lot Code: UH1-54-28 5JNMPD UH1-54-28 EDTMND UH1-54-28 HE2MND UH1-54-28 KX6MKD UH1-54-28 LPYMNA UH1-54-28 NARMKD

Product code KWL

K800207Class IIUhr Universal6hip ReplacementOsteonics Corp. / cleared 1980-02-11

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)