FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Reliance PF Femoral Stem
- Recall number
- Z-0108-06
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Reliance PF Femoral Stem
- Status
- Terminated
- Initiated
- 2005-08-24
- Posted
- 2005-11-01
- Terminated
- 2006-04-05
- Reason
- The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems.
- Root cause
- Other
- Action
- A urgent product recall notification was sent out to all hospitals on August 24, 2005, branches and agencies by first class mail. The action is limited only to that product manufactured in the Stryker Ireland facility for the product families indicated.
- Quantity
- 8487 units
- Distribution
- nationwide
- Lot, serial or model codes
- Catalog #---Description---- # of lots: 6265-2-000, Reliance PF Hip #0/10MM, 386 lots; 6265-2-001, Reliance PF Hip #1/11MM, 484 lots; 6265-2-002, Reliance PF Hip #2/12MM, 617 lots; 6265-2-003, Reliance PF Hip #3/13MM, 692 lots; 6265-2-004, Reliance PF Hip #4/14MM, 465 lots; 6265-2-005, Reliance PF Hip #5/15MM, 299 lots; 6265-2-006, Reliance PF Hip #6/16MM, 184 lots; 6265-2-007, Reliance PF Hip #7/17MM, 138 lots.
- 510(k) numbers
- ["K970200"]
- PMA numbers
- not on file
- Product code
- MAY
- 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