FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics: Interax Knee Midi 1 Tibial Inserts. IX HC Tib Ins Midi 1 14mm R.
- Recall number
- Z-0858-03
- Recalling firm
- Stryker Howmedica Osteonics
- Product
- Interax Knee Midi 1 Tibial Inserts. IX HC Tib Ins Midi 1 14mm R.
- Status
- Terminated
- Initiated
- 2003-01-23
- Posted
- 2003-05-21
- Terminated
- 2004-12-01
- Reason
- The device is demonstrating early wear and delamination.
- Root cause
- Other
- Action
- Recall letters were sent to the Howmedica branches and hospitals on January 23, 2003 via FedEx.
- Quantity
- 1
- Distribution
- Howmedica distributed this device to 2 Howmedica branches and 3 hospitals are Parkview Episcopal Hospital, Pueblo, CO; St. Mary Corwin Hospital, Pueblo, CO; and Hement Valley Hospital, Riverside, CA.
- Lot, serial or model codes
- Catalog No. 66402334 Lot MAXT
- 510(k) numbers
- ["K973121"]
- PMA numbers
- not on file
- Product code
- JWH
- 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