FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Triathlon X3 CR Tibial Bearing Insert Size #7 - 11MM Ref # 5530-G-711 2011-09 Howmedica Osteonics Corp.
- Recall number
- Z-0400-2007
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Triathlon X3 CR Tibial Bearing Insert Size #7 - 11MM Ref # 5530-G-711 2011-09 Howmedica Osteonics Corp.
- Status
- Terminated
- Initiated
- 2006-12-04
- Posted
- 2007-02-08
- Terminated
- 2007-02-21
- Reason
- A product mix -up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Size # 7 - 11MM and vice versa.
- Root cause
- Other
- Action
- Notification letters and Product Accountability forms were sent on 12/8/2006 by Federal Express with return receipt.
- Quantity
- 24 units
- Distribution
- Nationwide and Canada.
- Lot, serial or model codes
- Ref 5330-G-711 Lot G9XF7 LAF978
- 510(k) numbers
- ["K051146"]
- 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