FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 50 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
- Recall number
- Z-0635-2008
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 50 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
- Status
- Terminated
- Initiated
- 2007-10-26
- Posted
- 2008-03-20
- Terminated
- 2010-01-27
- Reason
- Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- 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
- 360 total
- Distribution
- Worldwide Distribution - USA, Canada, China, India, Australia, Korea, Singapore, Taiwan, Sweden, Germany, Netherlands, France, Spain, Italy, Poland, South Africa, and England.
- Lot, serial or model codes
- Ref No: Description: Lot Code: UH1-50-26 UHR BIPOLAR 26X50mm 6X5MAD UH1-50-26 UHR BIPOLAR 26X50mm J3VMKA UH1-50-26 UHR BIPOLAR 26X50mm J84MDA UH1-50-26 KJ1MEA UH1-50-26 KJ4MEA UH1-50-26 KJ8MEA UH1-50-26 KJ9MEA UH1-50-26 KJAMEA
- 510(k) numbers
- ["K800207"]
- PMA numbers
- not on file
- Product code
- KWL
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28