Z-1231-2007

Triathlon X3 Total Stabilizer + Tibial Insert For use with Triathlon Universal Baseplates, knee prosthesis...

Name: Z-1231-2007 Triathlon X3 Total Stabilizer + Tibial Insert For use with Triathlon Universal Baseplates, knee prosthesis...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2007-07-31
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2007-07-31 / Terminated / root cause: packaging

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Triathlon X3 Total Stabilizer + Tibial Insert For use with Triathlon Universal Baseplates, knee prosthesis. #5 13mm Stryker Orthopaedics on 2007-07-31. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1231-2007
Status: Terminated
Initiated: 2007-07-31
Posted: 2007-09-25
Terminated: 2007-12-05
Recalling firm: Howmedica Osteonics Corp
Product: Triathlon X3 Total Stabilizer + Tibial Insert For use with Triathlon Universal Baseplates, knee prosthesis. #5 13mm Stryker Orthopaedics
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: 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 tag: packaging
FDA root cause: Other
Action: Recall notification letters and product acknowledgment forms were send via Federal Express on August 2, 2007.
Quantity in commerce: 14
Distribution: Product distributed to 5 hospitals in GA, OH, MN, TX.
Product codes and lots: 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

Product code JWH

K070095Class IITriathlon Ts Knee SystemHowmedica Osteonics Corp. / cleared 2007-06-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)