FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Triathlon X3 Total Stabilizer + Tibial Insert For use with Triathlon Universal Baseplates, knee prosthesis. #5 13mm Stryker Orthopaedics
- Recall number
- Z-1231-2007
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Triathlon X3 Total Stabilizer + Tibial Insert For use with Triathlon Universal Baseplates, knee prosthesis. #5 13mm Stryker Orthopaedics
- Status
- Terminated
- Initiated
- 2007-07-31
- Posted
- 2007-09-25
- Terminated
- 2007-12-05
- Reason
- Stabilizer posts, packaged with the Triathlon TS Plus Tibial inserts have a specification anomaly related to length, resulting in a potential for the post to slightly protrude above the top surface of the plastic post.
- Root cause
- Other
- Action
- Recall notification letters and product acknowledgment forms were send via Federal Express on August 2, 2007.
- Quantity
- 14
- Distribution
- Product distributed to 5 hospitals in GA, OH, MN, TX.
- Lot, serial or model codes
- Product numbers: 5537-G-109, 5537-G-111, 5537-G-113, 5537-G-116, 5537-G-119, 5537-G-122, 5537-G-125, 5537-G-128, 5537-G-131, 5537-G-209, 5537-G-211, 5537-G-213, 5537-G-216, 5537-G-219, 5537-G-222, 5537-G-225, 5537-G-228, 5537-G-231, 5537-G-309, 5537-G-311, 5537-G-313, 5537-G-316, 5537-G-319, 5537-G-322, 5537-G-325, 5537-G-328, 5537-G-331, 5537-G-409, 5537-G-411, 5537-G-413, 5537-G-416, 5537-G-419, 5537-G-422, 5537-G-425, 5537-G-428, 5537-G-431, 5537-G-509, 5537-G-511, 5537-G-513, 5537-G-516, 5537-G-519, 5537-G-522, 5537-G-525, 5537-G-528, 5537-G-531, 5537-G-609, 5537-G-611, 5537-G-613, 5537-G-616, 5537-G-619, 5537-G-622, 5537-G-625, 5537-G-628, 5537-G-631, 5537-G-709, 5537-G-711, 5537-G-713, 5537-G-716, 5537-G-719, 5537-G-722, 5537-G-725, 5537-G-728, 5537-G-731, 5537-G-809, 5537-G-811, 5537-G-813, 5537-G-816, 5537-G-819, 5537-G-822, 5537-G-825, 5537-G-828, 5537-G-831. All lot codes
- 510(k) numbers
- ["K070095"]
- 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